Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial
Fat-soluble vitamin deficiency remains a challenge in cystic fibrosis (CF), chronic pancreatitis, and biliary atresia. Liposomes and cyclodextrins can enhance their bioavailability, thus this multi-center randomized placebo-controlled trial compared three-month supplementation of fat-soluble vitamin...
Gespeichert in:
| Veröffentlicht in: | Nutrients 2021-12, Vol.13 (12), p.4554 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | |
|---|---|
| container_issue | 12 |
| container_start_page | 4554 |
| container_title | Nutrients |
| container_volume | 13 |
| creator | Nowak, Jan K Sobkowiak, Paulina Drzymała-Czyż, Sławomira Krzyżanowska-Jankowska, Patrycja Sapiejka, Ewa Skorupa, Wojciech Pogorzelski, Andrzej Nowicka, Agata Wojsyk-Banaszak, Irena Kurek, Szymon Zielińska-Psuja, Barbara Lisowska, Aleksandra Walkowiak, Jarosław |
| description | Fat-soluble vitamin deficiency remains a challenge in cystic fibrosis (CF), chronic pancreatitis, and biliary atresia. Liposomes and cyclodextrins can enhance their bioavailability, thus this multi-center randomized placebo-controlled trial compared three-month supplementation of fat-soluble vitamins in the form of liposomes or cyclodextrins to medium-chain triglycerides (MCT) in pancreatic-insufficient CF patients. The daily doses were as follows: 2000 IU of retinyl palmitate, 4000 IU of vitamin D3, 200 IU of RRR-α-tocopherol, and 200 µg of vitamin K2 as menaquinone-7, with vitamin E given in soybean oil instead of liposomes. All participants received 4 mg of β-carotene and 1.07 mg of vitamin K1 to ensure compliance with the guidelines. The primary outcome was the change from the baseline of all-trans-retinol and 25-hydroxyvitamin D3 concentrations and the percentage of undercarboxylated osteocalcin. Out of 75 randomized patients (
= 28 liposomes,
= 22 cyclodextrins, and
= 25 MCT), 67 completed the trial (89%;
= 26 liposomes,
= 18 cyclodextrins, and
= 23 MCT) and had a median age of 22 years (IQR 19-28), body mass index of 20.6 kg/m
[18.4-22.0], and forced expiratory volume in 1 s of 65% (44-84%). The liposomal formulation of vitamin A was associated with the improved evolution of serum all-trans-retinol compared to the control (median +1.7 ng/mL (IQR -44.3-86.1) vs. -38.8 ng/mL (-71.2-6.8),
= 0.028). Cyclodextrins enhanced the bioavailability of vitamin D3 (+9.0 ng/mL (1.0-17.0) vs. +3.0 ng/mL (-4.0-7.0),
= 0.012) and vitamin E (+4.34 µg/mL (0.33-6.52) vs. -0.34 µg/mL (-1.71-2.15),
= 0.010). Liposomes may augment the bioavailability of vitamin A and cyclodextrins may strengthen the supplementation of vitamins D3 and E relative to MCT in pancreatic-insufficient CF but further studies are required to assess liposomal vitamin E (German Clinical Trial Register number DRKS00014295, funded from EU and Norsa Pharma). |
| doi_str_mv | 10.3390/nu13124554 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8706805</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2615113438</sourcerecordid><originalsourceid>FETCH-LOGICAL-c406t-919648a992f0e23da92c4b9d31ea79a86a762589524c4732dafa5c7f2ed747aa3</originalsourceid><addsrcrecordid>eNpdkd9qFTEQxhdRbKm98QEk4I1IV_Nvk40XQll6VDgi2NbbZU6SPU3JJttkVzy-hi9sDq21mpuZJL_5mJmvqp4T_IYxhd-GhTBCedPwR9UhxZLWQnD2-EF-UB3nfI33R2Ip2NPqgHElMMHisPq1grk-j37ZeIu-uRlGF9D5Mk3ejjbMMLsY0GV2YYvWboo5jjafoG6nfTT2x5xcKNeY0Gdr3DLW3RWU-ovktn6nbXLGZlQeul2enUYrt0kxu_wOnaKvEEwc3U9rUBfDnKL3JS2V4J9VTwbw2R7fxaPqcnV20X2s118-fOpO17XmWMy1IkrwFpSiA7aUGVBU840yjFiQCloBUtCmVQ3lmktGDQzQaDlQaySXAOyoen-rOy2b0Rpd5k3g-ym5EdKuj-D6f3-Cu-q38XvfSixa3BSBV3cCKd4sNs_96LK23kOwcck9FaQhhHHWFvTlf-h1XFIo4-0p2lLcSl6o17eULnvKyQ73zRDc7-3u_9pd4BcP279H_5jLfgMTtaeK</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2612820874</pqid></control><display><type>article</type><title>Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial</title><source>MDPI - Multidisciplinary Digital Publishing Institute</source><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>PubMed Central Open Access</source><creator>Nowak, Jan K ; Sobkowiak, Paulina ; Drzymała-Czyż, Sławomira ; Krzyżanowska-Jankowska, Patrycja ; Sapiejka, Ewa ; Skorupa, Wojciech ; Pogorzelski, Andrzej ; Nowicka, Agata ; Wojsyk-Banaszak, Irena ; Kurek, Szymon ; Zielińska-Psuja, Barbara ; Lisowska, Aleksandra ; Walkowiak, Jarosław</creator><creatorcontrib>Nowak, Jan K ; Sobkowiak, Paulina ; Drzymała-Czyż, Sławomira ; Krzyżanowska-Jankowska, Patrycja ; Sapiejka, Ewa ; Skorupa, Wojciech ; Pogorzelski, Andrzej ; Nowicka, Agata ; Wojsyk-Banaszak, Irena ; Kurek, Szymon ; Zielińska-Psuja, Barbara ; Lisowska, Aleksandra ; Walkowiak, Jarosław</creatorcontrib><description>Fat-soluble vitamin deficiency remains a challenge in cystic fibrosis (CF), chronic pancreatitis, and biliary atresia. Liposomes and cyclodextrins can enhance their bioavailability, thus this multi-center randomized placebo-controlled trial compared three-month supplementation of fat-soluble vitamins in the form of liposomes or cyclodextrins to medium-chain triglycerides (MCT) in pancreatic-insufficient CF patients. The daily doses were as follows: 2000 IU of retinyl palmitate, 4000 IU of vitamin D3, 200 IU of RRR-α-tocopherol, and 200 µg of vitamin K2 as menaquinone-7, with vitamin E given in soybean oil instead of liposomes. All participants received 4 mg of β-carotene and 1.07 mg of vitamin K1 to ensure compliance with the guidelines. The primary outcome was the change from the baseline of all-trans-retinol and 25-hydroxyvitamin D3 concentrations and the percentage of undercarboxylated osteocalcin. Out of 75 randomized patients (
= 28 liposomes,
= 22 cyclodextrins, and
= 25 MCT), 67 completed the trial (89%;
= 26 liposomes,
= 18 cyclodextrins, and
= 23 MCT) and had a median age of 22 years (IQR 19-28), body mass index of 20.6 kg/m
[18.4-22.0], and forced expiratory volume in 1 s of 65% (44-84%). The liposomal formulation of vitamin A was associated with the improved evolution of serum all-trans-retinol compared to the control (median +1.7 ng/mL (IQR -44.3-86.1) vs. -38.8 ng/mL (-71.2-6.8),
= 0.028). Cyclodextrins enhanced the bioavailability of vitamin D3 (+9.0 ng/mL (1.0-17.0) vs. +3.0 ng/mL (-4.0-7.0),
= 0.012) and vitamin E (+4.34 µg/mL (0.33-6.52) vs. -0.34 µg/mL (-1.71-2.15),
= 0.010). Liposomes may augment the bioavailability of vitamin A and cyclodextrins may strengthen the supplementation of vitamins D3 and E relative to MCT in pancreatic-insufficient CF but further studies are required to assess liposomal vitamin E (German Clinical Trial Register number DRKS00014295, funded from EU and Norsa Pharma).</description><identifier>ISSN: 2072-6643</identifier><identifier>EISSN: 2072-6643</identifier><identifier>DOI: 10.3390/nu13124554</identifier><identifier>PMID: 34960106</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject><![CDATA[Adolescent ; Adult ; Antibiotics ; beta Carotene - administration & dosage ; Biliary atresia ; Bioavailability ; Biomedical materials ; Body mass ; Body mass index ; Body size ; Calcifediol - blood ; Carotene ; Chains ; Cholecalciferol - administration & dosage ; Cholecalciferol - blood ; Clinical trials ; Cyclodextrin ; Cyclodextrins ; Cyclodextrins - chemistry ; Cystic fibrosis ; Cystic Fibrosis - diet therapy ; Dietary Supplements ; Drug dosages ; Exocrine Pancreatic Insufficiency - diet therapy ; Female ; Humans ; Liposomes ; Liposomes - chemistry ; Male ; Menaquinones ; Nutrient deficiency ; Osteocalcin ; Palmitic acid ; Pancreas ; Pancreatitis ; Patients ; Pharmaceuticals ; Retinene ; Soybean oil ; Soybeans ; Tocopherol ; Treatment Outcome ; Triglycerides ; Triglycerides - chemistry ; Vitamin A ; Vitamin A - administration & dosage ; Vitamin A - blood ; Vitamin D - administration & dosage ; Vitamin D - blood ; Vitamin D3 ; Vitamin deficiency ; Vitamin E ; Vitamin E - administration & dosage ; Vitamin E - blood ; Vitamin K 2 - administration & dosage ; Vitamin K 2 - analogs & derivatives ; Vitamins ; Vitamins - administration & dosage ; Vitamins - blood ; Vitamins - chemistry ; Young Adult ; β-Carotene]]></subject><ispartof>Nutrients, 2021-12, Vol.13 (12), p.4554</ispartof><rights>2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 by the authors. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c406t-919648a992f0e23da92c4b9d31ea79a86a762589524c4732dafa5c7f2ed747aa3</citedby><cites>FETCH-LOGICAL-c406t-919648a992f0e23da92c4b9d31ea79a86a762589524c4732dafa5c7f2ed747aa3</cites><orcidid>0000-0001-6724-1499 ; 0000-0001-8676-9803 ; 0000-0003-2737-8946 ; 0000-0001-5813-5707 ; 0000-0003-0953-2188</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8706805/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8706805/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34960106$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nowak, Jan K</creatorcontrib><creatorcontrib>Sobkowiak, Paulina</creatorcontrib><creatorcontrib>Drzymała-Czyż, Sławomira</creatorcontrib><creatorcontrib>Krzyżanowska-Jankowska, Patrycja</creatorcontrib><creatorcontrib>Sapiejka, Ewa</creatorcontrib><creatorcontrib>Skorupa, Wojciech</creatorcontrib><creatorcontrib>Pogorzelski, Andrzej</creatorcontrib><creatorcontrib>Nowicka, Agata</creatorcontrib><creatorcontrib>Wojsyk-Banaszak, Irena</creatorcontrib><creatorcontrib>Kurek, Szymon</creatorcontrib><creatorcontrib>Zielińska-Psuja, Barbara</creatorcontrib><creatorcontrib>Lisowska, Aleksandra</creatorcontrib><creatorcontrib>Walkowiak, Jarosław</creatorcontrib><title>Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial</title><title>Nutrients</title><addtitle>Nutrients</addtitle><description>Fat-soluble vitamin deficiency remains a challenge in cystic fibrosis (CF), chronic pancreatitis, and biliary atresia. Liposomes and cyclodextrins can enhance their bioavailability, thus this multi-center randomized placebo-controlled trial compared three-month supplementation of fat-soluble vitamins in the form of liposomes or cyclodextrins to medium-chain triglycerides (MCT) in pancreatic-insufficient CF patients. The daily doses were as follows: 2000 IU of retinyl palmitate, 4000 IU of vitamin D3, 200 IU of RRR-α-tocopherol, and 200 µg of vitamin K2 as menaquinone-7, with vitamin E given in soybean oil instead of liposomes. All participants received 4 mg of β-carotene and 1.07 mg of vitamin K1 to ensure compliance with the guidelines. The primary outcome was the change from the baseline of all-trans-retinol and 25-hydroxyvitamin D3 concentrations and the percentage of undercarboxylated osteocalcin. Out of 75 randomized patients (
= 28 liposomes,
= 22 cyclodextrins, and
= 25 MCT), 67 completed the trial (89%;
= 26 liposomes,
= 18 cyclodextrins, and
= 23 MCT) and had a median age of 22 years (IQR 19-28), body mass index of 20.6 kg/m
[18.4-22.0], and forced expiratory volume in 1 s of 65% (44-84%). The liposomal formulation of vitamin A was associated with the improved evolution of serum all-trans-retinol compared to the control (median +1.7 ng/mL (IQR -44.3-86.1) vs. -38.8 ng/mL (-71.2-6.8),
= 0.028). Cyclodextrins enhanced the bioavailability of vitamin D3 (+9.0 ng/mL (1.0-17.0) vs. +3.0 ng/mL (-4.0-7.0),
= 0.012) and vitamin E (+4.34 µg/mL (0.33-6.52) vs. -0.34 µg/mL (-1.71-2.15),
= 0.010). Liposomes may augment the bioavailability of vitamin A and cyclodextrins may strengthen the supplementation of vitamins D3 and E relative to MCT in pancreatic-insufficient CF but further studies are required to assess liposomal vitamin E (German Clinical Trial Register number DRKS00014295, funded from EU and Norsa Pharma).</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antibiotics</subject><subject>beta Carotene - administration & dosage</subject><subject>Biliary atresia</subject><subject>Bioavailability</subject><subject>Biomedical materials</subject><subject>Body mass</subject><subject>Body mass index</subject><subject>Body size</subject><subject>Calcifediol - blood</subject><subject>Carotene</subject><subject>Chains</subject><subject>Cholecalciferol - administration & dosage</subject><subject>Cholecalciferol - blood</subject><subject>Clinical trials</subject><subject>Cyclodextrin</subject><subject>Cyclodextrins</subject><subject>Cyclodextrins - chemistry</subject><subject>Cystic fibrosis</subject><subject>Cystic Fibrosis - diet therapy</subject><subject>Dietary Supplements</subject><subject>Drug dosages</subject><subject>Exocrine Pancreatic Insufficiency - diet therapy</subject><subject>Female</subject><subject>Humans</subject><subject>Liposomes</subject><subject>Liposomes - chemistry</subject><subject>Male</subject><subject>Menaquinones</subject><subject>Nutrient deficiency</subject><subject>Osteocalcin</subject><subject>Palmitic acid</subject><subject>Pancreas</subject><subject>Pancreatitis</subject><subject>Patients</subject><subject>Pharmaceuticals</subject><subject>Retinene</subject><subject>Soybean oil</subject><subject>Soybeans</subject><subject>Tocopherol</subject><subject>Treatment Outcome</subject><subject>Triglycerides</subject><subject>Triglycerides - chemistry</subject><subject>Vitamin A</subject><subject>Vitamin A - administration & dosage</subject><subject>Vitamin A - blood</subject><subject>Vitamin D - administration & dosage</subject><subject>Vitamin D - blood</subject><subject>Vitamin D3</subject><subject>Vitamin deficiency</subject><subject>Vitamin E</subject><subject>Vitamin E - administration & dosage</subject><subject>Vitamin E - blood</subject><subject>Vitamin K 2 - administration & dosage</subject><subject>Vitamin K 2 - analogs & derivatives</subject><subject>Vitamins</subject><subject>Vitamins - administration & dosage</subject><subject>Vitamins - blood</subject><subject>Vitamins - chemistry</subject><subject>Young Adult</subject><subject>β-Carotene</subject><issn>2072-6643</issn><issn>2072-6643</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNpdkd9qFTEQxhdRbKm98QEk4I1IV_Nvk40XQll6VDgi2NbbZU6SPU3JJttkVzy-hi9sDq21mpuZJL_5mJmvqp4T_IYxhd-GhTBCedPwR9UhxZLWQnD2-EF-UB3nfI33R2Ip2NPqgHElMMHisPq1grk-j37ZeIu-uRlGF9D5Mk3ejjbMMLsY0GV2YYvWboo5jjafoG6nfTT2x5xcKNeY0Gdr3DLW3RWU-ovktn6nbXLGZlQeul2enUYrt0kxu_wOnaKvEEwc3U9rUBfDnKL3JS2V4J9VTwbw2R7fxaPqcnV20X2s118-fOpO17XmWMy1IkrwFpSiA7aUGVBU840yjFiQCloBUtCmVQ3lmktGDQzQaDlQaySXAOyoen-rOy2b0Rpd5k3g-ym5EdKuj-D6f3-Cu-q38XvfSixa3BSBV3cCKd4sNs_96LK23kOwcck9FaQhhHHWFvTlf-h1XFIo4-0p2lLcSl6o17eULnvKyQ73zRDc7-3u_9pd4BcP279H_5jLfgMTtaeK</recordid><startdate>20211220</startdate><enddate>20211220</enddate><creator>Nowak, Jan K</creator><creator>Sobkowiak, Paulina</creator><creator>Drzymała-Czyż, Sławomira</creator><creator>Krzyżanowska-Jankowska, Patrycja</creator><creator>Sapiejka, Ewa</creator><creator>Skorupa, Wojciech</creator><creator>Pogorzelski, Andrzej</creator><creator>Nowicka, Agata</creator><creator>Wojsyk-Banaszak, Irena</creator><creator>Kurek, Szymon</creator><creator>Zielińska-Psuja, Barbara</creator><creator>Lisowska, Aleksandra</creator><creator>Walkowiak, Jarosław</creator><general>MDPI AG</general><general>MDPI</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6724-1499</orcidid><orcidid>https://orcid.org/0000-0001-8676-9803</orcidid><orcidid>https://orcid.org/0000-0003-2737-8946</orcidid><orcidid>https://orcid.org/0000-0001-5813-5707</orcidid><orcidid>https://orcid.org/0000-0003-0953-2188</orcidid></search><sort><creationdate>20211220</creationdate><title>Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial</title><author>Nowak, Jan K ; Sobkowiak, Paulina ; Drzymała-Czyż, Sławomira ; Krzyżanowska-Jankowska, Patrycja ; Sapiejka, Ewa ; Skorupa, Wojciech ; Pogorzelski, Andrzej ; Nowicka, Agata ; Wojsyk-Banaszak, Irena ; Kurek, Szymon ; Zielińska-Psuja, Barbara ; Lisowska, Aleksandra ; Walkowiak, Jarosław</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c406t-919648a992f0e23da92c4b9d31ea79a86a762589524c4732dafa5c7f2ed747aa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antibiotics</topic><topic>beta Carotene - administration & dosage</topic><topic>Biliary atresia</topic><topic>Bioavailability</topic><topic>Biomedical materials</topic><topic>Body mass</topic><topic>Body mass index</topic><topic>Body size</topic><topic>Calcifediol - blood</topic><topic>Carotene</topic><topic>Chains</topic><topic>Cholecalciferol - administration & dosage</topic><topic>Cholecalciferol - blood</topic><topic>Clinical trials</topic><topic>Cyclodextrin</topic><topic>Cyclodextrins</topic><topic>Cyclodextrins - chemistry</topic><topic>Cystic fibrosis</topic><topic>Cystic Fibrosis - diet therapy</topic><topic>Dietary Supplements</topic><topic>Drug dosages</topic><topic>Exocrine Pancreatic Insufficiency - diet therapy</topic><topic>Female</topic><topic>Humans</topic><topic>Liposomes</topic><topic>Liposomes - chemistry</topic><topic>Male</topic><topic>Menaquinones</topic><topic>Nutrient deficiency</topic><topic>Osteocalcin</topic><topic>Palmitic acid</topic><topic>Pancreas</topic><topic>Pancreatitis</topic><topic>Patients</topic><topic>Pharmaceuticals</topic><topic>Retinene</topic><topic>Soybean oil</topic><topic>Soybeans</topic><topic>Tocopherol</topic><topic>Treatment Outcome</topic><topic>Triglycerides</topic><topic>Triglycerides - chemistry</topic><topic>Vitamin A</topic><topic>Vitamin A - administration & dosage</topic><topic>Vitamin A - blood</topic><topic>Vitamin D - administration & dosage</topic><topic>Vitamin D - blood</topic><topic>Vitamin D3</topic><topic>Vitamin deficiency</topic><topic>Vitamin E</topic><topic>Vitamin E - administration & dosage</topic><topic>Vitamin E - blood</topic><topic>Vitamin K 2 - administration & dosage</topic><topic>Vitamin K 2 - analogs & derivatives</topic><topic>Vitamins</topic><topic>Vitamins - administration & dosage</topic><topic>Vitamins - blood</topic><topic>Vitamins - chemistry</topic><topic>Young Adult</topic><topic>β-Carotene</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nowak, Jan K</creatorcontrib><creatorcontrib>Sobkowiak, Paulina</creatorcontrib><creatorcontrib>Drzymała-Czyż, Sławomira</creatorcontrib><creatorcontrib>Krzyżanowska-Jankowska, Patrycja</creatorcontrib><creatorcontrib>Sapiejka, Ewa</creatorcontrib><creatorcontrib>Skorupa, Wojciech</creatorcontrib><creatorcontrib>Pogorzelski, Andrzej</creatorcontrib><creatorcontrib>Nowicka, Agata</creatorcontrib><creatorcontrib>Wojsyk-Banaszak, Irena</creatorcontrib><creatorcontrib>Kurek, Szymon</creatorcontrib><creatorcontrib>Zielińska-Psuja, Barbara</creatorcontrib><creatorcontrib>Lisowska, Aleksandra</creatorcontrib><creatorcontrib>Walkowiak, Jarosław</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Nutrients</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nowak, Jan K</au><au>Sobkowiak, Paulina</au><au>Drzymała-Czyż, Sławomira</au><au>Krzyżanowska-Jankowska, Patrycja</au><au>Sapiejka, Ewa</au><au>Skorupa, Wojciech</au><au>Pogorzelski, Andrzej</au><au>Nowicka, Agata</au><au>Wojsyk-Banaszak, Irena</au><au>Kurek, Szymon</au><au>Zielińska-Psuja, Barbara</au><au>Lisowska, Aleksandra</au><au>Walkowiak, Jarosław</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial</atitle><jtitle>Nutrients</jtitle><addtitle>Nutrients</addtitle><date>2021-12-20</date><risdate>2021</risdate><volume>13</volume><issue>12</issue><spage>4554</spage><pages>4554-</pages><issn>2072-6643</issn><eissn>2072-6643</eissn><abstract>Fat-soluble vitamin deficiency remains a challenge in cystic fibrosis (CF), chronic pancreatitis, and biliary atresia. Liposomes and cyclodextrins can enhance their bioavailability, thus this multi-center randomized placebo-controlled trial compared three-month supplementation of fat-soluble vitamins in the form of liposomes or cyclodextrins to medium-chain triglycerides (MCT) in pancreatic-insufficient CF patients. The daily doses were as follows: 2000 IU of retinyl palmitate, 4000 IU of vitamin D3, 200 IU of RRR-α-tocopherol, and 200 µg of vitamin K2 as menaquinone-7, with vitamin E given in soybean oil instead of liposomes. All participants received 4 mg of β-carotene and 1.07 mg of vitamin K1 to ensure compliance with the guidelines. The primary outcome was the change from the baseline of all-trans-retinol and 25-hydroxyvitamin D3 concentrations and the percentage of undercarboxylated osteocalcin. Out of 75 randomized patients (
= 28 liposomes,
= 22 cyclodextrins, and
= 25 MCT), 67 completed the trial (89%;
= 26 liposomes,
= 18 cyclodextrins, and
= 23 MCT) and had a median age of 22 years (IQR 19-28), body mass index of 20.6 kg/m
[18.4-22.0], and forced expiratory volume in 1 s of 65% (44-84%). The liposomal formulation of vitamin A was associated with the improved evolution of serum all-trans-retinol compared to the control (median +1.7 ng/mL (IQR -44.3-86.1) vs. -38.8 ng/mL (-71.2-6.8),
= 0.028). Cyclodextrins enhanced the bioavailability of vitamin D3 (+9.0 ng/mL (1.0-17.0) vs. +3.0 ng/mL (-4.0-7.0),
= 0.012) and vitamin E (+4.34 µg/mL (0.33-6.52) vs. -0.34 µg/mL (-1.71-2.15),
= 0.010). Liposomes may augment the bioavailability of vitamin A and cyclodextrins may strengthen the supplementation of vitamins D3 and E relative to MCT in pancreatic-insufficient CF but further studies are required to assess liposomal vitamin E (German Clinical Trial Register number DRKS00014295, funded from EU and Norsa Pharma).</abstract><cop>Switzerland</cop><pub>MDPI AG</pub><pmid>34960106</pmid><doi>10.3390/nu13124554</doi><orcidid>https://orcid.org/0000-0001-6724-1499</orcidid><orcidid>https://orcid.org/0000-0001-8676-9803</orcidid><orcidid>https://orcid.org/0000-0003-2737-8946</orcidid><orcidid>https://orcid.org/0000-0001-5813-5707</orcidid><orcidid>https://orcid.org/0000-0003-0953-2188</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2072-6643 |
| ispartof | Nutrients, 2021-12, Vol.13 (12), p.4554 |
| issn | 2072-6643 2072-6643 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8706805 |
| source | MDPI - Multidisciplinary Digital Publishing Institute; MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access |
| subjects | Adolescent Adult Antibiotics beta Carotene - administration & dosage Biliary atresia Bioavailability Biomedical materials Body mass Body mass index Body size Calcifediol - blood Carotene Chains Cholecalciferol - administration & dosage Cholecalciferol - blood Clinical trials Cyclodextrin Cyclodextrins Cyclodextrins - chemistry Cystic fibrosis Cystic Fibrosis - diet therapy Dietary Supplements Drug dosages Exocrine Pancreatic Insufficiency - diet therapy Female Humans Liposomes Liposomes - chemistry Male Menaquinones Nutrient deficiency Osteocalcin Palmitic acid Pancreas Pancreatitis Patients Pharmaceuticals Retinene Soybean oil Soybeans Tocopherol Treatment Outcome Triglycerides Triglycerides - chemistry Vitamin A Vitamin A - administration & dosage Vitamin A - blood Vitamin D - administration & dosage Vitamin D - blood Vitamin D3 Vitamin deficiency Vitamin E Vitamin E - administration & dosage Vitamin E - blood Vitamin K 2 - administration & dosage Vitamin K 2 - analogs & derivatives Vitamins Vitamins - administration & dosage Vitamins - blood Vitamins - chemistry Young Adult β-Carotene |
| title | Fat-Soluble Vitamin Supplementation Using Liposomes, Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-02T19%3A11%3A30IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Fat-Soluble%20Vitamin%20Supplementation%20Using%20Liposomes,%20Cyclodextrins,%20or%20Medium-Chain%20Triglycerides%20in%20Cystic%20Fibrosis:%20A%20Randomized%20Controlled%20Trial&rft.jtitle=Nutrients&rft.au=Nowak,%20Jan%20K&rft.date=2021-12-20&rft.volume=13&rft.issue=12&rft.spage=4554&rft.pages=4554-&rft.issn=2072-6643&rft.eissn=2072-6643&rft_id=info:doi/10.3390/nu13124554&rft_dat=%3Cproquest_pubme%3E2615113438%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2612820874&rft_id=info:pmid/34960106&rfr_iscdi=true |