Trial · NCT00100230

DHA and X-Linked Retinitis Pigmentosa

NCT00100230, Phase 2, Completed, Retina Foundation of the Southwest; results first posted 2015-03-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. DHA and X-Linked Retinitis Pigmentosa. Trials, record NCT00100230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00100230

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: DHA and X-Linked Retinitis Pigmentosa
NCT number: NCT00100230
Status: Completed
Phases: Phase 2
Enrollment: 78 participants, actual
Lead sponsor: Retina Foundation of the Southwest
Conditions: Retinitis Pigmentosa, X-linked Genetic Diseases
Interventions: docosahexaenoic acid OR corn/soy oil placebo
First posted: 2004-12-28
Last updated: 2015-03-17
Results first posted: 2015-03-17
Limitations and caveats: A lower than expected event rate for the primary outcome measure was the major trial limitation.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rate of LOSS of 31 Hertz Cone Electroretinographic Function	4 years	Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of 31 hertz cone electroretinographic response in this 4-year trial.
Secondary	Rate of LOSS of Rod Electroretinographic Function	4 years	Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of rod electroretinographic response in this 4-year trial.
Other	Loss of Peripheral Visual Fields	4 years	Hypothesis: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of peripheral visual fields in this 4-year trial.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of LOSS of 31 Hertz Cone Electroretinographic Function	4 years	Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)	log microvolts/year	MEAN
SECONDARY	Rate of LOSS of Rod Electroretinographic Function	4 years	Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)	change in amplitude, log microvolts/year	MEAN
OTHER_PRE_SPECIFIED	Loss of Peripheral Visual Fields	4 years	Only participants completing at least one year of trial	decibels (dB)	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Rate of LOSS of 31 Hertz Cone Electroretinographic Function	DHA (Docosahexaenoic Acid)	0.028	Standard Error 0.001	log microvolts/year
Rate of LOSS of 31 Hertz Cone Electroretinographic Function	Placebo (Corn/Soy Oil)	0.022	Standard Error 0.002	log microvolts/year
Rate of LOSS of Rod Electroretinographic Function	DHA (Docosahexaenoic Acid)	0.010	Standard Error 0.001	change in amplitude, log microvolts/year
Rate of LOSS of Rod Electroretinographic Function	Placebo (Corn/Soy Oil)	0.023	Standard Error 0.001	change in amplitude, log microvolts/year
Loss of Peripheral Visual Fields	DHA (Docosahexaenoic Acid) ARM	50.4	Standard Error 3.2	decibels (dB)
Loss of Peripheral Visual Fields	Placebo (Corn/Soy Oil) ARM	112.8	Standard Error 2.0	decibels (dB)

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1. Docosahexaenoic Acid (DHA) Arm	41
Overall Study	STARTED	Corn/Soy Oil Placebo Arm	37
Overall Study	COMPLETED	1. Docosahexaenoic Acid (DHA) Arm	29
Overall Study	COMPLETED	Corn/Soy Oil Placebo Arm	22
Overall Study	NOT COMPLETED	1. Docosahexaenoic Acid (DHA) Arm	12
Overall Study	NOT COMPLETED	Corn/Soy Oil Placebo Arm	15

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Stomach ache	Gastrointestinal disorders	1. Docosahexaenoic Acid (DHA) Arm	2	33	2
other	Stomach ache	Gastrointestinal disorders	Corn/Soy Oil Placebo Arm	1	27	1
other	Nausea	Gastrointestinal disorders	1. Docosahexaenoic Acid (DHA) Arm	1	33	1
other	Nausea	Gastrointestinal disorders	Corn/Soy Oil Placebo Arm	2	27	3
other	Low HDL cholesterol	Blood and lymphatic system disorders	1. Docosahexaenoic Acid (DHA) Arm	2	33	2
other	Low HDL cholesterol	Blood and lymphatic system disorders	Corn/Soy Oil Placebo Arm	5	27	5
other	elevated LDL cholesterol	Blood and lymphatic system disorders	1. Docosahexaenoic Acid (DHA) Arm	2	33	2
other	elevated LDL cholesterol	Blood and lymphatic system disorders	Corn/Soy Oil Placebo Arm	0	27	0
other	elevated total cholesterol	Blood and lymphatic system disorders	1. Docosahexaenoic Acid (DHA) Arm	2	33	2
other	elevated total cholesterol	Blood and lymphatic system disorders	Corn/Soy Oil Placebo Arm	1	27	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1. Docosahexaenoic Acid (DHA) Arm
Total, all-cause mortality	Corn/Soy Oil Placebo Arm
Total, other adverse events	1. Docosahexaenoic Acid (DHA) Arm	9	33
Total, other adverse events	Corn/Soy Oil Placebo Arm	16	27
Total, serious adverse events	1. Docosahexaenoic Acid (DHA) Arm	0	33
Total, serious adverse events	Corn/Soy Oil Placebo Arm	0	27

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23828615	DERIVED	PubMed
24805262	RESULT	PubMed
25015354	RESULT	PubMed
25342618	DERIVED	PubMed
26469750	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01FD002543	Phase 2 Study of High Dose DHA for the Treatment of X-Linked Retinitis Pigmentosa	HOFFMAN, DENNIS R	RETINA FOUNDATION OF THE SOUTHWEST	FOOD AND DRUG ADMINISTRATION	2005 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
1. Docosahexaenoic Acid (DHA) Arm vs Corn/Soy Oil Placebo Arm: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00100230

GET https://conductscience.org/api/trials/v1/NCT00100230/registered

API reference For AI assistants