drugset / Trial / NCT00346333
Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.
Timeline
- Start
- 2003-07
- Primary completion
- 2008-12
- Completion
- 2008-12
Outcome
Missed primary endpoint
paper No significant difference in rate of decline was found between the lutein plus vitamin A and control plus vitamin A groups over a 4-year interval PMID 20385935 ↗
registry Control Plus Vitamin A vs Lutein Plus Vitamin A; p = 0.66; Longitudinal regression analysis NCT00346333 ↗
registry Control Plus Vitamin A vs Lutein Plus Vitamin A; p = 0.52; Clustered Wilcoxon NCT00346333 ↗
Publications
- Results Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Brockhurst RJ, Hayes KC, Johnson EJ, Anderson EJ, Johnson CA, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A. Arch Ophthalmol. 2010 Apr;128(4):403-11. doi: 10.1001/archophthalmol.2010.32.
- Comander J, Weigel DiFranco C, Sanderson K, Place E, Maher M, Zampaglione E, Zhao Y, Huckfeldt RM, Bujakowska KM, Pierce E. Natural history of retinitis pigmentosa based on genotype, vitamin A/E supplementation, and an electroretinogram biomarker. JCI Insight. 2023 Aug 8;8(15):e167546. doi: 10.1172/jci.insight.167546.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lutein | Other / unclassified | 12 mg | — |