Night BlindnessNCT00569023
Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
A study testing alga Dunaliella bardawil in people with Night Blindness, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To assess the effect of oral administration of the alga Dunaliella bardawil containing approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Night Blindness
- What is being tested?
- alga Dunaliella bardawil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2007to Jul 2010
- 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 to 75 years
- All sexes
- 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
- Diagnosed with Fundus albipunctatus
- Isolated rod response markedly reduced (less than 20% of normal)after 20 minutes dark adaptation and improved by 50% after 2 hours
- Negative maximal response (a wave to b wave ratio less than 2)
- Retinal midperipheral white dots (More than 3000 dots)
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.
Show all 18Show fewer
- History of alcohol abuse or drug abuse, or both.
- Active liver disease or hepatic dysfunction as defined by elevations of 2.0 times the ULN in any of the following liver function tests: ALT, AST or bilirubin.
- Serum CPK > 2.0 times ULN in visit 0
- TSH above the normal range.
- Newly diagnosed diabetes within 3 months.
- 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.
- Serum creatinine > 2.0 mg/dl before the treatment phase, +3 proteinuria in urine dipstick, or a history of renal transplantation before the treatment period.
- Subject whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated within the 3 month prior to enrollment.
- Forbidden medications: the combination of PPAR alpha agonists-fibric acid derivatives, PPAR gamma agonists.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the effect of oral administration of the alga Dunaliella bardawil containing approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).
- Conditions
- Night Blindness
- Being tested
- alga Dunaliella bardawil
- Keywords
- Beta Carotene, visual functions, Fundus albipunctatus, Night Blindness
- Medical subject headings
- Night Blindness, Fundus Albipunctatus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alga Dunaliella bardawilDietary supplement
Each patients will be treated with four capsules daily of Dunaliella bardawil for 90 days.
Alga Dunaliella bardawil containing 15 mg approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers
| Study group | Role | What they receive |
|---|---|---|
| A,1,I | Experimental | Not described Receives: Dietary Supplement: alga Dunaliella bardawil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroretinogram responses
Measured: Three months
Secondary outcomes (1)
Visual acuity
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Night BlindnessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ygal Rotenstreich, Sheba Medical Center
- Investigators
- Ygal Rotenstreich, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569023
- Sponsor's protocol ID
- SHEBA-06-4496-YR-CTIL
- Status last verified
- Jun 2012
- First submitted
- 5 Dec 2007
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
- ClinicalTrials.gov ID
- NCT00569023
- Acronym / sponsor ID
- SHEBA-06-4496-YR-CTIL
- Conditions
- Night Blindness
- Keywords
- Beta Carotene, visual functions, Fundus albipunctatus, Night Blindness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Dec 2007 (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.
To assess the effect of oral administration of the alga Dunaliella bardawil containing approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A,1,I | Experimental | Dietary Supplement: alga Dunaliella bardawil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent to participate in the study.
- Men or women aged 18 years or older
- Diagnosed with Fundus albipunctatus
Key exclusion criteria (18 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 bardawilEach patients will be treated with four capsules daily of Dunaliella bardawil for 90 days. Alga Dunaliella bardawil containing 15 mg approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers | Dietary supplement | A,1,I |
Primary outcome
Electroretinogram responses
Time frame: Three months
1 secondary outcome
Visual acuity
Time frame: Three Months
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 28 Jun 2012.
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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.
Ygal Rotenstreich, MD principal investigator
Sheba Medical Center
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 in people with Night Blindness, 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 6 inclusion and 18 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 28 Jun 2012. 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. 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 responses (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2012.