Retinitis PigmentosaNCT01256697
The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella Bardawil on Visual Functions im Patients With Retinitis Pigmentosa
A study testing Alga Dunaliella Bardawil, Alga Dunaliella Bardawill and Sugar pill in people with Retinitis Pigmentosa, run by Sheba Medical Center at 1 site in Israel.
Trial summary
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]. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Alga Dunaliella Bardawil, Alga Dunaliella Bardawill and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent to participate in the study.
- Men or women aged 18 years or older.
- Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa
Who cannot join
- Current smokers.
- Current use of Vitamin A/ beta carotene supplements.
- Active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke, and coronary artery bypass graft (CABG) surgery.
- History of malignancy, except basal or squamous cell skin carcinoma.
- Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception.
- Uncontrolled hypertension defined as either resting diastolic blood pressure of >95mmHg (taken from the mean of 3 readings) or resting systolic blood Pressure of > 180 mmHg.
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- History of alcohol abuse or drug abuse, or both.
- Patient plans to engage in vigorous exercise or an aggressive diet regimen.
- Uncontrolled endocrine or metabolic disease.
- Participation in another investigational drug study within 4 weeks of entry into this study.
- Serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella
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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Alga Dunaliella Bardawil, Alga Dunaliella Bardawill, Sugar pill
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alga Dunaliella BardawilDietary supplement
9-cis Rich Powder
Alga Dunaliella BardawillDietary supplement
9-cis Rich Powder
Sugar pillOther
Sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Alga Dunaliella Bardawil | Experimental | Not described Receives: Dietary Supplement: Alga Dunaliella Bardawil; Dietary Supplement: Alga Dunaliella Bardawill |
| Sugar pill | Placebo comparator | Not described Receives: Other: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts
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 eye.
Measured: 1 year
Secondary outcomes (1)
The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2
Kinetic visual field for chromatic stimuli will be recorded in both eye after 30 minutes of dark adaptation. area of vision within the isopter will be measured by software in cm2.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ygal Rotenstreich, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256697
- Sponsor's protocol ID
- SHEBA -08-5086-YR-CTIL
- Status last verified
- Dec 2013
- First submitted
- 25 Feb 2010
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rotenstreich Y, Belkin M, Sadetzki S, Chetrit A, Ferman-Attar G, Sher I, Harari A, Shaish A, Harats D. Treatment with 9-cis beta-carotene-rich powder in patients with retinitis pigmentosa: a randomized crossover trial. JAMA Ophthalmol. 2013 Aug;131(8):985-92. doi: 10.1001/jamaophthalmol.2013.147.
PubMed 23700011Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.
PubMed 32573764
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Administration of 9-cis Rich Powder of the Alga Dunaliella
- ClinicalTrials.gov ID
- NCT01256697
- Acronym / sponsor ID
- SHEBA -08-5086-YR-CTIL
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alga Dunaliella Bardawil | Experimental | Dietary Supplement: Alga Dunaliella Bardawil, Dietary Supplement: Alga Dunaliella Bardawill |
| Sugar pill | Placebo comparator | Other: Sugar pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent to participate in the study.
- Men or women aged 18 years or older.
- Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa
Key exclusion criteria (12 listed)
- Current smokers.
- Current use of Vitamin A/ beta carotene supplements.
- Active arterial disease within 3 months of study entry such as unstable angina, myocardial infarction, transient ischemic attack (TIA), stroke, and coronary artery bypass graft (CABG) surgery.
- History of malignancy, except basal or squamous cell skin carcinoma.
- Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alga Dunaliella Bardawil9-cis Rich Powder | Dietary supplement | Alga Dunaliella Bardawil |
| Alga Dunaliella Bardawill9-cis Rich Powder | Dietary supplement | Alga Dunaliella Bardawil |
| Sugar pillSugar pill | Other | Sugar pill |
Primary outcome
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 eye.
1 secondary outcome
The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- Results publication: PubMed 23700011Rotenstreich Y, Belkin M, Sadetzki S, Chetrit A, Ferman-Attar G, Sher I, Harari A, Shaish A, Harats D. Treatment with 9-cis beta-carotene-rich powder in patients with retinitis pigmentosa: a randomized crossover trial. JAMA Ophthalmol. 2013 Aug;131(8):985-92. doi: 10.1001/jamaophthalmol.2013.147.
- Derived from this study: PubMed 32573764Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alga Dunaliella Bardawil, Alga Dunaliella Bardawill and Sugar pill in people with Retinitis Pigmentosa, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroretinogram scotopic maxiamal b-wave amplitude responses in microvolts (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256697, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013.