Vitamin D in Armenia: Vitamin D Repletion Strategies With Dibase, and Vitamin D and Vitamin D Binding Protein and COVID

NCT ID: NCT06406543

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-10-28

Brief 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). 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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vitamin D3 (Cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

an oral solution of vitamin D in a refined olive oil solution

Medium dose, medial frequency vitamin D repletion

50,000 IU oral solution weekly for 12 weeks, followed by 25,000 weekly for 24 weeks

Group Type: EXPERIMENTAL

Vitamin D3 (Cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

an oral solution of vitamin D in a refined olive oil solution

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

Group Type: EXPERIMENTAL

Vitamin D3 (Cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

an oral solution of vitamin D in a refined olive oil solution

Interventions

Vitamin D3 (Cholecalciferol)

an oral solution of vitamin D in a refined olive oil solution

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age 18 to 75
• Willing to participate in the study
• No vitamin D supplements for at least 1 year

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Osteoporosis Center of Armenia

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Bilezikian, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine

Locations

Osteoporosis Center of Armenia

Yerevan, , Armenia

Countries

Armenia

Other Identifiers

AAAT5256

Identifier Type: -

Identifier Source: org_study_id