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The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions in Adolescent Patients With Retinitis Pigmentosa

S

Sheba Medical Center

Status and phase

Begins enrollment in 1 month
Phase 2
Phase 1

Conditions

Retinitis Pigmentosa

Treatments

Dietary Supplement: Alga Dunaliella Bardawil powder
Dietary Supplement: Placebo:Starch

Study type

Interventional

Funder types

Other

Identifiers

NCT02018692
SHEBA-13-9579-YR-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent to participate in the study.
  • Adolescent 12-18 years old.
  • Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa

Exclusion criteria

  • Currently a smoker
  • Current use of vitamin A/ β-carotene supplements
  • Active arterial disease within 3 months prior to enrolment in the study, e.g. unstable angina, myocardial infarction, transient ischemic attack, stroke, coronary artery bypass graft surgery
  • History of malignancy, excepting basal or squamous cell skin carcinoma
  • Females who are pregnant, or breast feeding, or are premenopausal but not using chemical or mechanical contraception
  • Uncontrolled hypertension, defined either as resting diastolic blood pressure >95 mmHg (taken from the mean of 3 readings) or as resting systolic blood pressure >180 mmHg
  • History of alcohol abuse or drug abuse or both
  • Intention to engage in vigorous exercise or an aggressive diet regimen
  • Uncontrolled endocrine or metabolic disease
  • Participation in another investigational drug study within 4 weeks prior to enrolment
  • Serious or unstable medical or psychological condition which, in the opinion of the PI, would compromise the subject's safety or successful participation in the study
  • Initiation of hormone replacement therapy or oral contraceptive therapy within 3 months prior to enrolment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Alga Dunaliella Bardawil 9-cis beta Carotene Rich Powder
Experimental group
Description:
15 patients will first receive the capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder (5mg/Kg) for 24 weeks. After 24 weeks of washout period they will receive capsule containing placebo (Starch) for 24 weeks.
Treatment:
Dietary Supplement: Placebo:Starch
Dietary Supplement: Alga Dunaliella Bardawil powder
Placebo (Starch)
Placebo Comparator group
Description:
The other 15 Patients will receive first the placebo (Starch) capsules for 24 weeks. After 24 weeks of washout period they will receive capsules containing the alga Dunaliella Bardawil 9-cis beta-Carotene rich powder .
Treatment:
Dietary Supplement: Placebo:Starch
Dietary Supplement: Alga Dunaliella Bardawil powder

Trial contacts and locations

1

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Central trial contact

Ygal Rotenstreich, MD

Data sourced from clinicaltrials.gov

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