NCT01256697

The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella

Completed NA Last updated 19 December 2013

What this trial tests

NA trial testing Alga Dunaliella Bardawil in Retinitis Pigmentosa in 34 participants. Completed in 1 January 2011.

Timeline

1 August 2008

Primary endpoint
1 April 2009

1 January 2011

Quick facts

Lead sponsor	Sheba Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	34
Start date	1 August 2008
Primary completion	1 April 2009
Estimated completion	1 January 2011
Sites	1 location across Israel

Drugs / interventions tested

• Alga Dunaliella Bardawil — full drug profile →
• Alga Dunaliella Bardawill
• Sugar pill

Conditions studied

• Retinitis Pigmentosa — all drugs for Retinitis Pigmentosa →

Sponsor

Sheba Medical Center

Who can join

18 and older, female only, with Retinitis Pigmentosa. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts
  Time frame: 1 year
  Using the protocol of the International Society for Clinical Electrophysiology of Vision and the UTAS 3000 system (LKC Technologies, Gaithersburg, MD), we recorded full-field electroretinographic responses from both eyes of each patient. The scotopic conditions, after 30 minutes of dark adaptation we recorded the maximal scotopic response. The b-wave amplitude responses will be messured in each ey

Sponsor's own description

Retinitis pigmentosa is a genetically determined disease consisting of progressive centripetal retinal degeneration starting in the rods outer segments. Its prevalence is 1:4000 people and is the fourth most common blinding disease in Israel in 2004 \[7% of all blindness\]. The investigators tried to treat 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 alga Dunaliella bardawil accumulates high concentration of β -carotene when grown under appropriate conditions. The β -carotene of the alga is composed of approximately 50% of all-trans - β carotene and 50% 9-cis β -carotene.

The 9-cis β -carotene has shown to be a precursor of 9-cis retinoic acid both in-vitro in human intestinal mucosa and in-vivo in a ferret, perfuse with 9-cis b-carotene. The night vision, as measured objectively by electroretinography (ERG) more than doubled in six patients tested. The visual field was also improved significantly.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment with 9-cis β-carotene-rich powder in patients with retinitis pigmentosa: a randomized crossover trial.
   Rotenstreich Y, Belkin M, Sadetzki S, Chetrit A, et al · · 2013 · cited 49× · PMID 23700011 · DOI 10.1001/jamaophthalmol.2013.147
2. Inherited Retinal Dystrophies: Role of Oxidative Stress and Inflammation in Their Physiopathology and Therapeutic Implications.
   Pinilla I, Maneu V, Campello L, Fernández-Sánchez L, et al · · 2022 · cited 30× · PMID 35739983 · DOI 10.3390/antiox11061086
3. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa.
   Schwartz SG, Wang X, Chavis P, Kuriyan AE, et al · · 2020 · cited 26× · PMID 32573764 · DOI 10.1002/14651858.cd008428.pub3
4. The Lrat^-/- Rat: CRISPR/Cas9 Construction and Phenotyping of a New Animal Model for Retinitis Pigmentosa.
   Koster C, van den Hurk KT, Lewallen CF, Talib M, et al · · 2021 · cited 10× · PMID 34281288 · DOI 10.3390/ijms22137234
5. Neuroprotection provided by polyphenols and flavonoids in photoreceptor degenerative diseases.
   de Lima-Vasconcellos TH, Bovi Dos Santos G, Móvio MI, Donnici GK, et al · · 2026 · cited 6× · PMID 40364630 · DOI 10.4103/nrr.nrr-d-24-01638
6. Nutritional supplements: current evidence for retinitis pigmentosa and Stargardt disease.
   Barthelemy N, Lee W, Gregori NZ, Lam BL, et al · · 2026 · PMID 41861379 · DOI 10.1097/icu.0000000000001213