Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT02018692
Brief Summary:
The aim of this study is to determine whether 9-cis-beta Caroten rich D. Brdawiil extract is effective in the treatment of retinitis pigmentosa in adolescent patients.
Detailed Description:
Retinitis pigmentosa is a genetically disease consisting of progressive retinal degeneration starting in the rods. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 \[7% of all blindness\]. The investigators treated a non-progressive form of the disease \[Fundus Albipunctatus\] by oral therapy of the food supplement made from alga Dunaliella Bardawil composed of approximately 50% 9-cis β-carotene.
The 9-cis β -carotene has been shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfused with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested following treatment. The visual field was also improved significantly. In a more recent study the investigators treated 29 retinitis pigmentosa patients with the 9-cis b Carotene algae Dunaliella Bardawil in a double masked placebo control cross over trial. Significant improvement in retinal function was recorded in 34% of the patients.
As a natural extension of this study we will perform a double-masked, randomized, crossover, placebo-controlled study for adolescent patients. Longer treatment duration will be tested: a 24 week treatment with either the 9-cis β-carotene-rich capsules or placebo followed by an additional a 24 week treatment with the other capsules and a wash-out period of 24 weeks between this two type of treatments. We predict that with this study design a maximal/increased therapeutic effect as well as efficient washout will be achieved.
Study:
NCT02018692
Study Brief:
Protocol Section:
NCT02018692