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CompletedNCT00569023Updated Jun 28, 2012

Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene

An interventional study of alga Dunaliella bardawil in Night Blindness, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-28.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Night Blindness

Keywords

  • Beta Carotene
  • visual functions
  • Fundus albipunctatus
  • Night Blindness
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent to participate in the study.
  • Men or women aged 18 years or older
  • Diagnosed with Fundus albipunctatus

    1. Isolated rod response markedly reduced (less than 20% of normal)after 20 minutes dark adaptation and improved by 50% after 2 hours
    2. Negative maximal response (a wave to b wave ratio less than 2)
    3. Retinal midperipheral white dots (More than 3000 dots)

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    A,1,I

    Dietary Supplement: alga Dunaliella bardawil

Interventions

  • Dietary supplementalga Dunaliella bardawil

    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

05

What researchers measure

Primary outcomes

  1. Electroretinogram responses

    Time frame: Three months

Secondary outcomes

  1. Visual acuity

    Time frame: Three Months

06

Study locations

1 site
  • Sheba Medical Center
    Tel Hashomer, 52621, Israel
07

Registry details

Key details

Study ID
NCT00569023
Lead sponsor
Sheba Medical Center
Responsible party
Dr. Ygal Rotenstreich (Opthalmologist, Sheba Medical Center) — Principal investigator
First posted
Dec 6, 2007
Start date
Jul 2007
Primary completion
Aug 2009
Completion
Jul 2010
Last update
Jun 28, 2012

Study contacts

Ygal Rotenstreich, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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