Docosahexaenoic Acid Slows Visual Field Progression in X-Linked Retinitis Pigmentosa: Ancillary Outcomes of the DHAX Trial
Docosahexaenoic acid (DHA) was supplemented in a single-site, placebo-controlled, randomized clinical trial designed to slow vision loss associated with X-linked retinitis pigmentosa (XLRP); the DHAX Trial. We previously reported no significant differences between supplemented and placebo groups in...
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| Veröffentlicht in: | Investigative ophthalmology & visual science 2015-10, Vol.56 (11), p.6646-6653 |
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| creator | Hoffman, Dennis R Hughbanks-Wheaton, Dianna K Spencer, Rand Fish, Gary E Pearson, N Shirlene Wang, Yi-Zhong Klein, Martin Takacs, Alison Locke, Kirsten G Birch, David G |
| description | Docosahexaenoic acid (DHA) was supplemented in a single-site, placebo-controlled, randomized clinical trial designed to slow vision loss associated with X-linked retinitis pigmentosa (XLRP); the DHAX Trial. We previously reported no significant differences between supplemented and placebo groups in intent-to-treat analysis of primary ERG outcomes. Assessed herein are hypothesis-generating measures of ancillary visual function outcomes in participants fully adhering to trial protocol.
Male participants with XLRP (range, 7-31 years) received 30 mg DHA/kg/d (n = 29) or placebo (n = 22) for 4 years. Visual outcomes were measured annually and red blood cell (RBC) DHA determined every 6 months.
Oral DHA supplementation increased mean RBC-DHA levels by 4-fold (P < 0.0001) over placebo. No group differences in progression were found for visual acuity (P = 0.11), shape discrimination (P = 0.18), or fundus appearance (P = 0.70). Optical coherence tomography (OCT) became available during year 2 of the trial; no group differences were seen in ellipsoid zone constriction (P = 0.87) over 2 years. Yearly rates of progression were reduced for dark-adapted thresholds (P = 0.06) and visual field sensitivity for foveal, macular, peripheral, total, and ellipsoid zone regions by DHA supplementation (P = 0.039, P = 0.031, P < 0.0001, P < 0.0001, and P = 0.033). Rates of visual field sensitivity decline were dependent on RBC-DHA (P = 0.046 to |
| doi_str_mv | 10.1167/iovs.15-17786 |
| format | Article |
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Male participants with XLRP (range, 7-31 years) received 30 mg DHA/kg/d (n = 29) or placebo (n = 22) for 4 years. Visual outcomes were measured annually and red blood cell (RBC) DHA determined every 6 months.
Oral DHA supplementation increased mean RBC-DHA levels by 4-fold (P < 0.0001) over placebo. No group differences in progression were found for visual acuity (P = 0.11), shape discrimination (P = 0.18), or fundus appearance (P = 0.70). Optical coherence tomography (OCT) became available during year 2 of the trial; no group differences were seen in ellipsoid zone constriction (P = 0.87) over 2 years. Yearly rates of progression were reduced for dark-adapted thresholds (P = 0.06) and visual field sensitivity for foveal, macular, peripheral, total, and ellipsoid zone regions by DHA supplementation (P = 0.039, P = 0.031, P < 0.0001, P < 0.0001, and P = 0.033). Rates of visual field sensitivity decline were dependent on RBC-DHA (P = 0.046 to <0.0001).
Supplementation of DHA significantly elevated blood DHA levels and reduced the rate of progression in final dark-adapted thresholds and visual field sensitivity. From the relationship between RBC-DHA and the rate of field sensitivity loss, we can extrapolate that an RBC-DHA level of 17% could minimize the decline in field sensitivity. (ClinicalTrials.gov number, NCT00100230.)</description><identifier>ISSN: 1552-5783</identifier><identifier>ISSN: 0146-0404</identifier><identifier>EISSN: 1552-5783</identifier><identifier>DOI: 10.1167/iovs.15-17786</identifier><identifier>PMID: 26469750</identifier><language>eng</language><publisher>United States: The Association for Research in Vision and Ophthalmology</publisher><subject>Adolescent ; Adult ; Child ; Clinical Trials ; Disease Progression ; Docosahexaenoic Acids - therapeutic use ; Form Perception - drug effects ; Fundus Oculi ; Genetic Diseases, X-Linked - drug therapy ; Humans ; Male ; Retinitis Pigmentosa - drug therapy ; Retinitis Pigmentosa - genetics ; Visual Fields - drug effects ; Young Adult</subject><ispartof>Investigative ophthalmology & visual science, 2015-10, Vol.56 (11), p.6646-6653</ispartof><rights>Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c453t-6f7696f66e39d3d8f5fff9b8ab95303a8edc9f13318810d2544205e573f6ac23</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5963311/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5963311/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26469750$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hoffman, Dennis R</creatorcontrib><creatorcontrib>Hughbanks-Wheaton, Dianna K</creatorcontrib><creatorcontrib>Spencer, Rand</creatorcontrib><creatorcontrib>Fish, Gary E</creatorcontrib><creatorcontrib>Pearson, N Shirlene</creatorcontrib><creatorcontrib>Wang, Yi-Zhong</creatorcontrib><creatorcontrib>Klein, Martin</creatorcontrib><creatorcontrib>Takacs, Alison</creatorcontrib><creatorcontrib>Locke, Kirsten G</creatorcontrib><creatorcontrib>Birch, David G</creatorcontrib><title>Docosahexaenoic Acid Slows Visual Field Progression in X-Linked Retinitis Pigmentosa: Ancillary Outcomes of the DHAX Trial</title><title>Investigative ophthalmology & visual science</title><addtitle>Invest Ophthalmol Vis Sci</addtitle><description>Docosahexaenoic acid (DHA) was supplemented in a single-site, placebo-controlled, randomized clinical trial designed to slow vision loss associated with X-linked retinitis pigmentosa (XLRP); the DHAX Trial. We previously reported no significant differences between supplemented and placebo groups in intent-to-treat analysis of primary ERG outcomes. Assessed herein are hypothesis-generating measures of ancillary visual function outcomes in participants fully adhering to trial protocol.
Male participants with XLRP (range, 7-31 years) received 30 mg DHA/kg/d (n = 29) or placebo (n = 22) for 4 years. Visual outcomes were measured annually and red blood cell (RBC) DHA determined every 6 months.
Oral DHA supplementation increased mean RBC-DHA levels by 4-fold (P < 0.0001) over placebo. No group differences in progression were found for visual acuity (P = 0.11), shape discrimination (P = 0.18), or fundus appearance (P = 0.70). Optical coherence tomography (OCT) became available during year 2 of the trial; no group differences were seen in ellipsoid zone constriction (P = 0.87) over 2 years. Yearly rates of progression were reduced for dark-adapted thresholds (P = 0.06) and visual field sensitivity for foveal, macular, peripheral, total, and ellipsoid zone regions by DHA supplementation (P = 0.039, P = 0.031, P < 0.0001, P < 0.0001, and P = 0.033). Rates of visual field sensitivity decline were dependent on RBC-DHA (P = 0.046 to <0.0001).
Supplementation of DHA significantly elevated blood DHA levels and reduced the rate of progression in final dark-adapted thresholds and visual field sensitivity. From the relationship between RBC-DHA and the rate of field sensitivity loss, we can extrapolate that an RBC-DHA level of 17% could minimize the decline in field sensitivity. (ClinicalTrials.gov number, NCT00100230.)</description><subject>Adolescent</subject><subject>Adult</subject><subject>Child</subject><subject>Clinical Trials</subject><subject>Disease Progression</subject><subject>Docosahexaenoic Acids - therapeutic use</subject><subject>Form Perception - drug effects</subject><subject>Fundus Oculi</subject><subject>Genetic Diseases, X-Linked - drug therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Retinitis Pigmentosa - drug therapy</subject><subject>Retinitis Pigmentosa - genetics</subject><subject>Visual Fields - drug effects</subject><subject>Young Adult</subject><issn>1552-5783</issn><issn>0146-0404</issn><issn>1552-5783</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkU1v1DAQhi0Eoh9w5Ip85JLij7UTc0BatZQirdQKVqg3y-uMdwcSu9hJofx6XFqqcvJIfvTMO3oJecXZEee6fYvpuhxx1fC27fQTss-VEo1qO_n00bxHDkr5xpjgXLDnZE_ohTatYvvk90nyqbgd_HIQE3q69NjTL0P6WehXLLMb6CnC0NOLnLYZSsEUKUZ62awwfoeefoYJI05Y6AVuR4hTtb2jy-hxGFy-oefz5NMIhaZApx3Qk7PlJV1ndMML8iy4ocDL-_eQrE8_rI_PmtX5x0_Hy1XjF0pOjQ6tNjpoDdL0su-CCiGYTec2RkkmXQe9N4FLybuOs16oxUIwBaqVQTsv5CF5f6e9mjdjZWvE7AZ7lXGs-WxyaP__ibiz23RtldFVyqvgzb0gpx8zlMmOWDzU8yKkuVjeCmGklIZVtLlDfU6lZAgPazizt3XZ27osV_ZvXZV__TjbA_2vH_kHTL6TUA</recordid><startdate>20151001</startdate><enddate>20151001</enddate><creator>Hoffman, Dennis R</creator><creator>Hughbanks-Wheaton, Dianna K</creator><creator>Spencer, Rand</creator><creator>Fish, Gary E</creator><creator>Pearson, N Shirlene</creator><creator>Wang, Yi-Zhong</creator><creator>Klein, Martin</creator><creator>Takacs, Alison</creator><creator>Locke, Kirsten G</creator><creator>Birch, David G</creator><general>The Association for Research in Vision and Ophthalmology</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20151001</creationdate><title>Docosahexaenoic Acid Slows Visual Field Progression in X-Linked Retinitis Pigmentosa: Ancillary Outcomes of the DHAX Trial</title><author>Hoffman, Dennis R ; Hughbanks-Wheaton, Dianna K ; Spencer, Rand ; Fish, Gary E ; Pearson, N Shirlene ; Wang, Yi-Zhong ; Klein, Martin ; Takacs, Alison ; Locke, Kirsten G ; Birch, David G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c453t-6f7696f66e39d3d8f5fff9b8ab95303a8edc9f13318810d2544205e573f6ac23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Child</topic><topic>Clinical Trials</topic><topic>Disease Progression</topic><topic>Docosahexaenoic Acids - therapeutic use</topic><topic>Form Perception - drug effects</topic><topic>Fundus Oculi</topic><topic>Genetic Diseases, X-Linked - drug therapy</topic><topic>Humans</topic><topic>Male</topic><topic>Retinitis Pigmentosa - drug therapy</topic><topic>Retinitis Pigmentosa - genetics</topic><topic>Visual Fields - drug effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hoffman, Dennis R</creatorcontrib><creatorcontrib>Hughbanks-Wheaton, Dianna K</creatorcontrib><creatorcontrib>Spencer, Rand</creatorcontrib><creatorcontrib>Fish, Gary E</creatorcontrib><creatorcontrib>Pearson, N Shirlene</creatorcontrib><creatorcontrib>Wang, Yi-Zhong</creatorcontrib><creatorcontrib>Klein, Martin</creatorcontrib><creatorcontrib>Takacs, Alison</creatorcontrib><creatorcontrib>Locke, Kirsten G</creatorcontrib><creatorcontrib>Birch, David G</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Investigative ophthalmology & visual science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hoffman, Dennis R</au><au>Hughbanks-Wheaton, Dianna K</au><au>Spencer, Rand</au><au>Fish, Gary E</au><au>Pearson, N Shirlene</au><au>Wang, Yi-Zhong</au><au>Klein, Martin</au><au>Takacs, Alison</au><au>Locke, Kirsten G</au><au>Birch, David G</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Docosahexaenoic Acid Slows Visual Field Progression in X-Linked Retinitis Pigmentosa: Ancillary Outcomes of the DHAX Trial</atitle><jtitle>Investigative ophthalmology & visual science</jtitle><addtitle>Invest Ophthalmol Vis Sci</addtitle><date>2015-10-01</date><risdate>2015</risdate><volume>56</volume><issue>11</issue><spage>6646</spage><epage>6653</epage><pages>6646-6653</pages><issn>1552-5783</issn><issn>0146-0404</issn><eissn>1552-5783</eissn><abstract>Docosahexaenoic acid (DHA) was supplemented in a single-site, placebo-controlled, randomized clinical trial designed to slow vision loss associated with X-linked retinitis pigmentosa (XLRP); the DHAX Trial. We previously reported no significant differences between supplemented and placebo groups in intent-to-treat analysis of primary ERG outcomes. Assessed herein are hypothesis-generating measures of ancillary visual function outcomes in participants fully adhering to trial protocol.
Male participants with XLRP (range, 7-31 years) received 30 mg DHA/kg/d (n = 29) or placebo (n = 22) for 4 years. Visual outcomes were measured annually and red blood cell (RBC) DHA determined every 6 months.
Oral DHA supplementation increased mean RBC-DHA levels by 4-fold (P < 0.0001) over placebo. No group differences in progression were found for visual acuity (P = 0.11), shape discrimination (P = 0.18), or fundus appearance (P = 0.70). Optical coherence tomography (OCT) became available during year 2 of the trial; no group differences were seen in ellipsoid zone constriction (P = 0.87) over 2 years. Yearly rates of progression were reduced for dark-adapted thresholds (P = 0.06) and visual field sensitivity for foveal, macular, peripheral, total, and ellipsoid zone regions by DHA supplementation (P = 0.039, P = 0.031, P < 0.0001, P < 0.0001, and P = 0.033). Rates of visual field sensitivity decline were dependent on RBC-DHA (P = 0.046 to <0.0001).
Supplementation of DHA significantly elevated blood DHA levels and reduced the rate of progression in final dark-adapted thresholds and visual field sensitivity. From the relationship between RBC-DHA and the rate of field sensitivity loss, we can extrapolate that an RBC-DHA level of 17% could minimize the decline in field sensitivity. (ClinicalTrials.gov number, NCT00100230.)</abstract><cop>United States</cop><pub>The Association for Research in Vision and Ophthalmology</pub><pmid>26469750</pmid><doi>10.1167/iovs.15-17786</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | Adolescent Adult Child Clinical Trials Disease Progression Docosahexaenoic Acids - therapeutic use Form Perception - drug effects Fundus Oculi Genetic Diseases, X-Linked - drug therapy Humans Male Retinitis Pigmentosa - drug therapy Retinitis Pigmentosa - genetics Visual Fields - drug effects Young Adult |
| title | Docosahexaenoic Acid Slows Visual Field Progression in X-Linked Retinitis Pigmentosa: Ancillary Outcomes of the DHAX Trial |
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