Vitamin D in Armenia: Vitamin D Repletion Strategies With Dibase, and Vitamin D and Vitamin D Binding Protein and COVID
Vitamin D in Armenia: Phase 2 - Vitamin D Repletion Strategies With Dibase, and Vitamin D and Vitamin D Binding Protein and COVID
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Data obtained from many epidemiological studies suggest that vitamin D deficiency is widespread throughout the world, despite increasing attention to the relationships between vitamin D deficiency and skeletal health as well as many other organ systems. This proposal is designed to optimally replace vitamin D deficient subjects with oral vitamin D solution (Dibase) among a well-characterized population whose mean vitamin D level have been established. In a recent nationwide study, this research team established that the country of Armenia has marginal levels of 25-hydoxyvitamin D among a free-living population of pre- and postmenopausal women: the average level was 19.76 ng/mL with 54% of subjects showing levels that are clearly insufficient. Equally impressive is the finding that fully 20% of women over 65 years of age, have levels that are below 12 ng/mL (< 30 nmol/l).
Following consent, all participants will receive a unique participant identification number, and will then complete a brief questionnaire regarding demographics, selected medical history, and contact information. All participants will then be directed to the EcoSense laboratory, where they will provide blood sample via venipuncture for vitamin D.
For those participants with a 25-hydroxyvitamin D level of less than 30 ng/mL, they will be called back to EcoSense laboratory where they will provide blood sample via venipuncture for calcium, and then brought to the Osteoporosis Center, where they will be randomly allocated into one of three treatment groups.
Participants will be instructed on how to dose the supplement as appropriate for their assigned arm, and then receive 4 weeks of the vitamin D supplement. Participants will return to the Osteoporosis Center at the end of week 4 to obtain an interval history, be assessed for any adverse reactions, compliance, or symptoms of infection or illness. Blood samples will be obtained at weeks 4, 8, 12, 24, and 36 for measurement of 25-hydroxyvitamin D and calcium at the collaborating laboratory as described above, and all participants will be informed of their lab test results as they become available.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Yerevan, Armenia
- Osteoporosis Center of Armenia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 75
- Willing to participate in the study
- No vitamin D supplements for at least 1 year
Exclusion Criteria:
- Not meeting inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low dose, high frequency vitamin D repletion
receive 7,000 IU oral drops daily for 12 weeks, followed by 3,500 IU daily for 24 weeks
|
an oral solution of vitamin D in a refined olive oil solution
|
|
Experimental: Medium dose, medial frequency vitamin D repletion
50,000 IU oral solution weekly for 12 weeks, followed by 25,000 weekly for 24 weeks
|
an oral solution of vitamin D in a refined olive oil solution
|
|
Experimental: High dose, low frequency vitamin D repletion
100,000 IU every other week for 12 weeks, followed by 50,000 every other week for 24 weeks
|
an oral solution of vitamin D in a refined olive oil solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vitamin D level
Time Frame: Baseline, 48 months
|
This is to examine the optimal repletion strategy for individuals with hypovitaminosis D. Blood tests will be performed to determine vitamin D levels.
|
Baseline, 48 months
|
|
VDBP level
Time Frame: Baseline, 48 months
|
This is to examine the optimal repletion strategy for individuals with hypovitaminosis D. Blood tests will be performed to determine Vitamin D Binding Protein (VDBP) levels.
|
Baseline, 48 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John Bilezikian, MD, Professor of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT5256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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