Evidence map›Paper›PMID 26469750›Full record

Trial reportInvestigative ophthalmology & visual science2015

Docosahexaenoic Acid Slows Visual Field Progression in X-Linked Retinitis Pigmentosa: Ancillary Outcomes of the DHAX Trial.

Dennis R Hoffman, Dianna K Hughbanks-Wheaton, Rand Spencer, Gary E Fish, N Shirlene Pearson, Yi-Zhong Wang, Martin Klein, Alison Takacs, Kirsten G Locke, David G Birch

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Investigative ophthalmology & visual science, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00100230 (Investigation of Effectiveness and Safety of High Dose Docosahexaenoic Acid), which is not on this map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00100230 phase2completednot on this map

Investigation of Effectiveness and Safety of High Dose Docosahexaenoic Acid (DHA) in X-Linked Retinitis Pigmentosa

TypeinterventionalSponsorRetina Foundation of the SouthwestRan2004 to 2014Enrolled78ConditionsRetinitis Pigmentosa, X-linked Genetic DiseasesArmsdocosahexaenoic acid OR corn/soy oil placebo
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  8. Review
  9. Article
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  13. Type 2 Usher Syndrome - A Cause for Sensorineural Hearing Loss.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2024
    Article
  14. Review
  15. External Disruption of Ocular DevelopmentThe Yale journal of biology and medicine · 2024
    Review
  16. Review
  17. Review
  18. Review
  19. Retinitis Pigmentosa: Current Clinical Management and Emerging Therapies.International journal of molecular sciences · 2023
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Dennis R HoffmanRetina Foundation of the Southwest, Dallas, Texas, United States 2Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, United States.
Dianna K Hughbanks-WheatonRetina Foundation of the Southwest, Dallas, Texas, United States 2Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, United States.
Rand SpencerTexas Retina Associates, Dallas, Texas, United States.
Gary E FishTexas Retina Associates, Dallas, Texas, United States.
N Shirlene PearsonCenter for Teaching Excellence, Southern Methodist University, Dallas, Texas, United States.
Yi-Zhong WangRetina Foundation of the Southwest, Dallas, Texas, United States 2Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, United States.
Martin KleinRetina Foundation of the Southwest, Dallas, Texas, United States.
Alison TakacsRetina Foundation of the Southwest, Dallas, Texas, United States.
Kirsten G LockeRetina Foundation of the Southwest, Dallas, Texas, United States.
David G BirchRetina Foundation of the Southwest, Dallas, Texas, United States 2Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, United States.
Retina Foundation of the Southwest · USThe University of Texas Southwestern Medical Center · USTexas Retina Associates (United States) · USSouthern Methodist University · USSouthwestern Medical Center · US

Funding

MEASURES OF HUMAN RECEPTOR AND POST RECEPTOR ACTIVITYR01EY009076 · NEI · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI BIRCH, DAVID G, HOOD, DONALD C. · 1991 to 2021
$8.3M
Phase 2 Study of High Dose DHA for the Treatment of X-Linked Retinitis PigmentosaR01FD002543 · FDA · RETINA FOUNDATION OF THE SOUTHWEST · PI HOFFMAN, DENNIS R · 2005 to 2013
$2.3M
FDA HHS 5R01FD002543FDA HHS R01 FD002543NEI NIH HHS R01 EY009076
6 · The paper itself

Abstract

purposeDocosahexaenoic 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.

methodsMale 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.

resultsOral 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).

conclusionsSupplementation 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.)

Indexed as

AdolescentAdultChildDisease ProgressionDocosahexaenoic AcidsForm PerceptionFundus OculiGenetic Diseases, X-LinkedHumansMaleRetinitis PigmentosaVisual FieldsYoung AdultDocosahexaenoic Acids

Identifiers

PMID26469750
PMCPMC5963311
OpenAlexW2400144185

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.