Figure 1.

Flowchart and Randomization in Docosahexaenoic Acid in X-Linked Retinitis Pigmentosa (DHAX) Trial

The modified intent-to-treat (mITT) cohort (n = 60) included data for trial participants completing at least the first-year annual visit. The per protocol cohort (n = 51) included participants following protocol and completing the 4-year trial. DHA indicates docosahexaenoic acid; XLRP, X-linked retinitis pigmentosa.

^aOne due to apathy (12 months), 1 due to seeing white circles (6 months), 2 due to lost contact (12 and 10 months), 2 due to parents being too busy to travel to Dallas (12 and 8 months), 1 due to depression from continued vision loss (4 months), and 1 due to floaters and increased sensitivity to light (2 months).

^bOne had a mutation in the choroideremia gene (CHD; REP-1) and the second had an autosomal recessive retinitis pigmentosa mutation (homozygous CNGB1 mutation). These mutations were identified after trial completion.

^cOne moved to Iraq, 2 due to apathy (15 and 19.5 months), 1 ran away from home (38 months), and 1 due to being “terribly sick and sore when taking capsules” (35 months).

^dThree lost to follow-up (0, 4, and 15 months), 1 due to apathy and difficulty in traveling to Dallas (12 months), 1 changed mind about participating and consumed no capsules (0 months), 1 due to apathy (9 months), 1 due to inconsistent bowel movements (8 months), and 1 due to dehydration and fatigue (5 months).

^eOne lost to follow-up (21 months), 1 due to apathy (21 months), and 1 due to capsules possibly exacerbating inflammatory bowel disease (24 months).

^fAdmitted in a posttrial interview to not taking capsules for most of the 4-year trial and was confirmed nonadherent by red blood cell DHA levels.