drugset / Trial / NCT03402789
Docosahexaenoic Acid (DHA) Supplementation in Amblyopia
RandomizedParallel-groupSingle-blindTreatment
Summary
This study evaluates the addition of docosahexaenoic acid (DHA) to eye patching in the treatment of residual amblyopia in children ages 3 to 18 years old. Two thirds of participants will receive DHA along with eye patching, while one third of participants will receive a placebo along with eye patching.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2024-07-01
- Completion
- 2024-12-30
Publications
- Background Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Dean TW, Beck RW, Siatkowski RM, Holmes JM, Beauchamp CL, Golden RP, Miller AM, Verderber LC, Wallace DK. A randomized trial of levodopa as treatment for residual amblyopia in older children. Ophthalmology. 2015 May;122(5):874-81. doi: 10.1016/j.ophtha.2015.01.002. Epub 2015 Feb 9.
- Background Moon K, Rao SC, Schulzke SM, Patole SK, Simmer K. Longchain polyunsaturated fatty acid supplementation in preterm infants. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD000375. doi: 10.1002/14651858.CD000375.pub5.
- Background Simmer K. Long-chain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database Syst Rev. 2001;(4):CD000376. doi: 10.1002/14651858.CD000376.
- Background Koletzko B, Cetin I, Brenna JT; Perinatal Lipid Intake Working Group; Child Health Foundation; Diabetic Pregnancy Study Group; European Association of Perinatal Medicine; European Association of Perinatal Medicine; European Society for Clinical Nutrition and Metabolism; European Society for Paediatric Gastroenterology, Hepatology and Nutrition, Committee on Nutrition; International Federation of Placenta Associations; International Society for the Study of Fatty Acids and Lipids. Dietary fat intakes for pregnant and lactating women. Br J Nutr. 2007 Nov;98(5):873-7. doi: 10.1017/S0007114507764747. Epub 2007 Aug 10.
- Background Kuratko CN, Barrett EC, Nelson EB, Salem N Jr. The relationship of docosahexaenoic acid (DHA) with learning and behavior in healthy children: a review. Nutrients. 2013 Jul 19;5(7):2777-810. doi: 10.3390/nu5072777.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DOCONEXENT | Other / unclassified | 1200 mg | Oral |