The effect of vitamin D supplementation on the outcome of treatment with bevacizumab in diabetic macular edema: a randomized clinical trial
Purpose Concomitant vitamin D deficiency (VDD) is speculated to aggravate diabetic macular edema (DME). We aimed to determine the effect of hypovitaminosis D correction on the outcome of treatment with intravitreal bevacizumab (IVB) in DME eyes. Methods In this randomized clinical trial, 83 eyes of...
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| Veröffentlicht in: | International ophthalmology 2022-11, Vol.42 (11), p.3345-3356 |
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| creator | Fekri, Sahba Soheilian, Masoud Roozdar, Sepehr Abtahi, Seyed-Hossein Nouri, Hosein |
| description | Purpose
Concomitant vitamin D deficiency (VDD) is speculated to aggravate diabetic macular edema (DME). We aimed to determine the effect of hypovitaminosis D correction on the outcome of treatment with intravitreal bevacizumab (IVB) in DME eyes.
Methods
In this randomized clinical trial, 83 eyes of 83 patients with DME were recruited and divided into three groups: normal vitamin D levels + IVB administration (Group 1), vitamin D insufficient/deficient + IVB administration (Group 2), and vitamin D insufficient/deficient + IVB administration + oral vitamin D supplementation (Group 3). Participants were followed for 6 months after the intervention. Visual (corrected distance visual acuity, CDVA) and anatomical (central macular thickness, CMT) outcomes of intervention were evaluated 1, 3, and 6 months after three monthly loading doses of IVB were given. Serum vitamin D levels were measured 1 and 6 months after the third IVB administration.
Results
A total of 29, 26, and 28 eyes were enrolled in groups 1, 2, and 3, respectively. In months 1, 3, and 6, after the three basic loading doses of IVB, visual acuity and CMT improved in all three groups, but improvements (both functional and anatomical) in groups 1 and 3 in month 6 were more significant than in group 2 (mean CDVA LogMAR changes: − 0.18 ± 0.03, − 0.14 ± 0.05, and − 0.2 ± 0.06; mean CMT reductions: − 82.24 ± 11.43, − 66.62 ± 14.34, and − 86.14 ± 18.36, in groups 1, 2, and 3, respectively;
p
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| doi_str_mv | 10.1007/s10792-022-02333-2 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9093557</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2662544257</sourcerecordid><originalsourceid>FETCH-LOGICAL-c404t-8116a8a49cd09291db71b76254880d7188ca882428f89baf5013521b4f191ea33</originalsourceid><addsrcrecordid>eNp9kctu1TAQhiMEoqXwAiyQJTZsAr4ksc0CCZVLkSp1U9bWxJn0uIrjg-0cRF-Bl8bpKW1hUdmWR5pvfs_4r6qXjL5llMp3iVGpeU35eoQQNX9UHbJWlqAT9PG9-KB6ltIlpVRL3T2tDkTbNkK14rD6fb5BguOINpMwkp3L4N1MPpG0bLcTepwzZBdmUnYuaFiyDR5XNkeEvALkp8sb0uMOrLtaPPSkKAwOeszOEg92mSASHNDDewIkwjwE765wIHZys7MwFS0H0_PqyQhTwhc391H1_cvn8-OT-vTs67fjj6e1bWiTa8VYBwoabQequWZDL1kvO942StFBMqUsKMUbrkalexhbykTLWd-MTDMEIY6qD3vd7dJ7HGwZIcJkttF5iL9MAGf-zcxuYy7Czmiqy8_JIvDmRiCGHwumbLxLFqcJZgxLMrxbu2n4Nfr6P_QyLHEu4xkuy1Kik6xQfE_ZGFKKON42w6hZvTZ7r03x2lx7bXgpenV_jNuSv-YWQOyBVFLzBca7tx-Q_QPehbYz</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2727283671</pqid></control><display><type>article</type><title>The effect of vitamin D supplementation on the outcome of treatment with bevacizumab in diabetic macular edema: a randomized clinical trial</title><source>SpringerNature Journals</source><creator>Fekri, Sahba ; Soheilian, Masoud ; Roozdar, Sepehr ; Abtahi, Seyed-Hossein ; Nouri, Hosein</creator><creatorcontrib>Fekri, Sahba ; Soheilian, Masoud ; Roozdar, Sepehr ; Abtahi, Seyed-Hossein ; Nouri, Hosein</creatorcontrib><description>Purpose
Concomitant vitamin D deficiency (VDD) is speculated to aggravate diabetic macular edema (DME). We aimed to determine the effect of hypovitaminosis D correction on the outcome of treatment with intravitreal bevacizumab (IVB) in DME eyes.
Methods
In this randomized clinical trial, 83 eyes of 83 patients with DME were recruited and divided into three groups: normal vitamin D levels + IVB administration (Group 1), vitamin D insufficient/deficient + IVB administration (Group 2), and vitamin D insufficient/deficient + IVB administration + oral vitamin D supplementation (Group 3). Participants were followed for 6 months after the intervention. Visual (corrected distance visual acuity, CDVA) and anatomical (central macular thickness, CMT) outcomes of intervention were evaluated 1, 3, and 6 months after three monthly loading doses of IVB were given. Serum vitamin D levels were measured 1 and 6 months after the third IVB administration.
Results
A total of 29, 26, and 28 eyes were enrolled in groups 1, 2, and 3, respectively. In months 1, 3, and 6, after the three basic loading doses of IVB, visual acuity and CMT improved in all three groups, but improvements (both functional and anatomical) in groups 1 and 3 in month 6 were more significant than in group 2 (mean CDVA LogMAR changes: − 0.18 ± 0.03, − 0.14 ± 0.05, and − 0.2 ± 0.06; mean CMT reductions: − 82.24 ± 11.43, − 66.62 ± 14.34, and − 86.14 ± 18.36, in groups 1, 2, and 3, respectively;
p
< 0.001). The mean number of IVB injections during follow-up was 5.33 (range 4–7), which did not differ between the groups.
Conclusion
Correction of vitamin D deficiency in DME patients with type 2 diabetes and vitamin D deficiency, in addition to IVB injections, may play a role in improving CDVA and CMT. However, this beneficial effect seems to be delayed by several months.
Trial registration
Iranian Registry of Clinical Trials (IRCT), IRCT20200407046978N1, registered on April 11, 2020, retrospectively registered (
https://en.irct.ir/trial/46999
).</description><identifier>ISSN: 1573-2630</identifier><identifier>ISSN: 0165-5701</identifier><identifier>EISSN: 1573-2630</identifier><identifier>DOI: 10.1007/s10792-022-02333-2</identifier><identifier>PMID: 35543853</identifier><language>eng</language><publisher>Dordrecht: Springer Netherlands</publisher><subject>Acuity ; Bevacizumab ; Calciferol ; Clinical trials ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Diabetic retinopathy ; Dietary supplements ; Edema ; Eye ; Medicine ; Medicine & Public Health ; Monoclonal antibodies ; Ophthalmology ; Original Paper ; Patients ; Visual acuity ; Vitamin D ; Vitamin deficiency</subject><ispartof>International ophthalmology, 2022-11, Vol.42 (11), p.3345-3356</ispartof><rights>The Author(s), under exclusive licence to Springer Nature B.V. 2022</rights><rights>2022. The Author(s), under exclusive licence to Springer Nature B.V.</rights><rights>The Author(s), under exclusive licence to Springer Nature B.V. 2022.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c404t-8116a8a49cd09291db71b76254880d7188ca882428f89baf5013521b4f191ea33</citedby><cites>FETCH-LOGICAL-c404t-8116a8a49cd09291db71b76254880d7188ca882428f89baf5013521b4f191ea33</cites><orcidid>0000-0003-1808-0443</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10792-022-02333-2$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10792-022-02333-2$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35543853$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fekri, Sahba</creatorcontrib><creatorcontrib>Soheilian, Masoud</creatorcontrib><creatorcontrib>Roozdar, Sepehr</creatorcontrib><creatorcontrib>Abtahi, Seyed-Hossein</creatorcontrib><creatorcontrib>Nouri, Hosein</creatorcontrib><title>The effect of vitamin D supplementation on the outcome of treatment with bevacizumab in diabetic macular edema: a randomized clinical trial</title><title>International ophthalmology</title><addtitle>Int Ophthalmol</addtitle><addtitle>Int Ophthalmol</addtitle><description>Purpose
Concomitant vitamin D deficiency (VDD) is speculated to aggravate diabetic macular edema (DME). We aimed to determine the effect of hypovitaminosis D correction on the outcome of treatment with intravitreal bevacizumab (IVB) in DME eyes.
Methods
In this randomized clinical trial, 83 eyes of 83 patients with DME were recruited and divided into three groups: normal vitamin D levels + IVB administration (Group 1), vitamin D insufficient/deficient + IVB administration (Group 2), and vitamin D insufficient/deficient + IVB administration + oral vitamin D supplementation (Group 3). Participants were followed for 6 months after the intervention. Visual (corrected distance visual acuity, CDVA) and anatomical (central macular thickness, CMT) outcomes of intervention were evaluated 1, 3, and 6 months after three monthly loading doses of IVB were given. Serum vitamin D levels were measured 1 and 6 months after the third IVB administration.
Results
A total of 29, 26, and 28 eyes were enrolled in groups 1, 2, and 3, respectively. In months 1, 3, and 6, after the three basic loading doses of IVB, visual acuity and CMT improved in all three groups, but improvements (both functional and anatomical) in groups 1 and 3 in month 6 were more significant than in group 2 (mean CDVA LogMAR changes: − 0.18 ± 0.03, − 0.14 ± 0.05, and − 0.2 ± 0.06; mean CMT reductions: − 82.24 ± 11.43, − 66.62 ± 14.34, and − 86.14 ± 18.36, in groups 1, 2, and 3, respectively;
p
< 0.001). The mean number of IVB injections during follow-up was 5.33 (range 4–7), which did not differ between the groups.
Conclusion
Correction of vitamin D deficiency in DME patients with type 2 diabetes and vitamin D deficiency, in addition to IVB injections, may play a role in improving CDVA and CMT. However, this beneficial effect seems to be delayed by several months.
Trial registration
Iranian Registry of Clinical Trials (IRCT), IRCT20200407046978N1, registered on April 11, 2020, retrospectively registered (
https://en.irct.ir/trial/46999
).</description><subject>Acuity</subject><subject>Bevacizumab</subject><subject>Calciferol</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetic retinopathy</subject><subject>Dietary supplements</subject><subject>Edema</subject><subject>Eye</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Monoclonal antibodies</subject><subject>Ophthalmology</subject><subject>Original Paper</subject><subject>Patients</subject><subject>Visual acuity</subject><subject>Vitamin D</subject><subject>Vitamin deficiency</subject><issn>1573-2630</issn><issn>0165-5701</issn><issn>1573-2630</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kctu1TAQhiMEoqXwAiyQJTZsAr4ksc0CCZVLkSp1U9bWxJn0uIrjg-0cRF-Bl8bpKW1hUdmWR5pvfs_4r6qXjL5llMp3iVGpeU35eoQQNX9UHbJWlqAT9PG9-KB6ltIlpVRL3T2tDkTbNkK14rD6fb5BguOINpMwkp3L4N1MPpG0bLcTepwzZBdmUnYuaFiyDR5XNkeEvALkp8sb0uMOrLtaPPSkKAwOeszOEg92mSASHNDDewIkwjwE765wIHZys7MwFS0H0_PqyQhTwhc391H1_cvn8-OT-vTs67fjj6e1bWiTa8VYBwoabQequWZDL1kvO942StFBMqUsKMUbrkalexhbykTLWd-MTDMEIY6qD3vd7dJ7HGwZIcJkttF5iL9MAGf-zcxuYy7Czmiqy8_JIvDmRiCGHwumbLxLFqcJZgxLMrxbu2n4Nfr6P_QyLHEu4xkuy1Kik6xQfE_ZGFKKON42w6hZvTZ7r03x2lx7bXgpenV_jNuSv-YWQOyBVFLzBca7tx-Q_QPehbYz</recordid><startdate>20221101</startdate><enddate>20221101</enddate><creator>Fekri, Sahba</creator><creator>Soheilian, Masoud</creator><creator>Roozdar, Sepehr</creator><creator>Abtahi, Seyed-Hossein</creator><creator>Nouri, Hosein</creator><general>Springer Netherlands</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7T7</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-1808-0443</orcidid></search><sort><creationdate>20221101</creationdate><title>The effect of vitamin D supplementation on the outcome of treatment with bevacizumab in diabetic macular edema: a randomized clinical trial</title><author>Fekri, Sahba ; Soheilian, Masoud ; Roozdar, Sepehr ; Abtahi, Seyed-Hossein ; Nouri, Hosein</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c404t-8116a8a49cd09291db71b76254880d7188ca882428f89baf5013521b4f191ea33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Acuity</topic><topic>Bevacizumab</topic><topic>Calciferol</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetic retinopathy</topic><topic>Dietary supplements</topic><topic>Edema</topic><topic>Eye</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Monoclonal antibodies</topic><topic>Ophthalmology</topic><topic>Original Paper</topic><topic>Patients</topic><topic>Visual acuity</topic><topic>Vitamin D</topic><topic>Vitamin deficiency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fekri, Sahba</creatorcontrib><creatorcontrib>Soheilian, Masoud</creatorcontrib><creatorcontrib>Roozdar, Sepehr</creatorcontrib><creatorcontrib>Abtahi, Seyed-Hossein</creatorcontrib><creatorcontrib>Nouri, Hosein</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</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</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</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>International ophthalmology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fekri, Sahba</au><au>Soheilian, Masoud</au><au>Roozdar, Sepehr</au><au>Abtahi, Seyed-Hossein</au><au>Nouri, Hosein</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effect of vitamin D supplementation on the outcome of treatment with bevacizumab in diabetic macular edema: a randomized clinical trial</atitle><jtitle>International ophthalmology</jtitle><stitle>Int Ophthalmol</stitle><addtitle>Int Ophthalmol</addtitle><date>2022-11-01</date><risdate>2022</risdate><volume>42</volume><issue>11</issue><spage>3345</spage><epage>3356</epage><pages>3345-3356</pages><issn>1573-2630</issn><issn>0165-5701</issn><eissn>1573-2630</eissn><abstract>Purpose
Concomitant vitamin D deficiency (VDD) is speculated to aggravate diabetic macular edema (DME). We aimed to determine the effect of hypovitaminosis D correction on the outcome of treatment with intravitreal bevacizumab (IVB) in DME eyes.
Methods
In this randomized clinical trial, 83 eyes of 83 patients with DME were recruited and divided into three groups: normal vitamin D levels + IVB administration (Group 1), vitamin D insufficient/deficient + IVB administration (Group 2), and vitamin D insufficient/deficient + IVB administration + oral vitamin D supplementation (Group 3). Participants were followed for 6 months after the intervention. Visual (corrected distance visual acuity, CDVA) and anatomical (central macular thickness, CMT) outcomes of intervention were evaluated 1, 3, and 6 months after three monthly loading doses of IVB were given. Serum vitamin D levels were measured 1 and 6 months after the third IVB administration.
Results
A total of 29, 26, and 28 eyes were enrolled in groups 1, 2, and 3, respectively. In months 1, 3, and 6, after the three basic loading doses of IVB, visual acuity and CMT improved in all three groups, but improvements (both functional and anatomical) in groups 1 and 3 in month 6 were more significant than in group 2 (mean CDVA LogMAR changes: − 0.18 ± 0.03, − 0.14 ± 0.05, and − 0.2 ± 0.06; mean CMT reductions: − 82.24 ± 11.43, − 66.62 ± 14.34, and − 86.14 ± 18.36, in groups 1, 2, and 3, respectively;
p
< 0.001). The mean number of IVB injections during follow-up was 5.33 (range 4–7), which did not differ between the groups.
Conclusion
Correction of vitamin D deficiency in DME patients with type 2 diabetes and vitamin D deficiency, in addition to IVB injections, may play a role in improving CDVA and CMT. However, this beneficial effect seems to be delayed by several months.
Trial registration
Iranian Registry of Clinical Trials (IRCT), IRCT20200407046978N1, registered on April 11, 2020, retrospectively registered (
https://en.irct.ir/trial/46999
).</abstract><cop>Dordrecht</cop><pub>Springer Netherlands</pub><pmid>35543853</pmid><doi>10.1007/s10792-022-02333-2</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0003-1808-0443</orcidid><oa>free_for_read</oa></addata></record> |
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| language | eng |
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| source | SpringerNature Journals |
| subjects | Acuity Bevacizumab Calciferol Clinical trials Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diabetic retinopathy Dietary supplements Edema Eye Medicine Medicine & Public Health Monoclonal antibodies Ophthalmology Original Paper Patients Visual acuity Vitamin D Vitamin deficiency |
| title | The effect of vitamin D supplementation on the outcome of treatment with bevacizumab in diabetic macular edema: a randomized clinical trial |
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