Vitamin D DeficiencyNCT06406543
Vitamin D in Armenia: Vitamin D Repletion Strategies With Dibase, and Vitamin D and Vitamin D Binding Protein and COVID
A study testing Vitamin D3 (Cholecalciferol) in people with Vitamin D Deficiency, run by Columbia University at 1 site in Armenia.
Trial summary
This is a three-arm unblinded prospective interventional study of vitamin D supplementation in participants with insufficient vitamin D at three different induction and maintenance dosing regimens (high dose, low frequency; medium dose, medium frequency, and low dose, high frequency). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3 (Cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteArmenia
- Study dates
- 1 Dec 2023to 28 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 75
- Willing to participate in the study
- No vitamin D supplements for at least 1 year
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D in Armenia: Phase 2 - Vitamin D Repletion Strategies With Dibase, and Vitamin D and Vitamin D Binding Protein and COVID
This is a three-arm unblinded prospective interventional study of vitamin D supplementation in participants with insufficient vitamin D at three different induction and maintenance dosing regimens (high dose, low frequency; medium dose, medium frequency, and low dose, high frequency). Measurements of serum vitamin D will take place at 4, 8, 12, 24, and 36 weeks, and will be compared to determine which regimen was most effective at achieving and maintaining ideal serum vitamin D levels.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3 (Cholecalciferol)
- Keywords
- Vitamin D repletion
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Cholecalciferol)Dietary supplement
an oral solution of vitamin D in a refined olive oil solution
| Study group | Role | What they receive |
|---|---|---|
| Low dose, high frequency vitamin D repletion | Experimental | receive 7,000 IU oral drops daily for 12 weeks, followed by 3,500 IU daily for 24 weeks Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) |
| Medium dose, medial frequency vitamin D repletion | Experimental | 50,000 IU oral solution weekly for 12 weeks, followed by 25,000 weekly for 24 weeks Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) |
| High dose, low frequency vitamin D repletion | Experimental | 100,000 IU every other week for 12 weeks, followed by 50,000 every other week for 24 weeks Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level
This is to examine the optimal repletion strategy for individuals with hypovitaminosis D. Blood tests will be performed to determine vitamin D levels.
Measured: Baseline, 48 months
VDBP level
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.
Measured: Baseline, 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Dec 2023
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Osteoporosis Center of Armenia
- Responsible party
- Sponsor
- Investigators
- John Bilezikian, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406543
- Sponsor's protocol ID
- AAAT5256
- Status last verified
- Apr 2025
- First submitted
- 7 May 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D in Armenia: Phase 2 - Vitamin D Repletion Strategies With Dibase, and Vitamin D and Vitamin D Binding Protein and COVID
- ClinicalTrials.gov ID
- NCT06406543
- Acronym / sponsor ID
- AAAT5256
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D repletion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Osteoporosis Center of Armenia
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 9 May 2024 (actual)
- 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.
This is a three-arm unblinded prospective interventional study of vitamin D supplementation in participants with insufficient vitamin D at three different induction and maintenance dosing regimens (high dose, low frequency; medium dose, medium frequency, and low dose, high frequency). Measurements of serum vitamin D will take place at 4, 8, 12, 24, and 36 weeks, and will be compared to determine which regimen was most effective at achieving and maintaining ideal serum vitamin D levels.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose, high frequency vitamin D repletion | Experimental | Dietary Supplement: Vitamin D3 (Cholecalciferol)receive 7,000 IU oral drops daily for 12 weeks, followed by 3,500 IU daily for 24 weeks |
| Medium dose, medial frequency vitamin D repletion | Experimental | Dietary Supplement: Vitamin D3 (Cholecalciferol)50,000 IU oral solution weekly for 12 weeks, followed by 25,000 weekly for 24 weeks |
| High dose, low frequency vitamin D repletion | Experimental | Dietary Supplement: Vitamin D3 (Cholecalciferol)100,000 IU every other week for 12 weeks, followed by 50,000 every other week for 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 75
- Willing to participate in the study
- No vitamin D supplements for at least 1 year
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| Vitamin D3 (Cholecalciferol)an oral solution of vitamin D in a refined olive oil solution | Dietary supplement | High dose, low frequency vitamin D repletion, Low dose, high frequency vitamin D repletion, Medium dose, medial frequency vitamin D repletion |
Primary outcome
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.
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.
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 27 Apr 2025.
- Individual participant dataSharing planned: No
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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.
John Bilezikian, MD principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (Cholecalciferol) in people with Vitamin D Deficiency, run by Columbia University at 1 site in Armenia.
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 1 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 27 Apr 2025. 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 Armenia. 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?
Vitamin D level (time frame: Baseline, 48 months). The study lists 2 primary outcomes in all. 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 27 Apr 2025.