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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D3 (Cholecalciferol)

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: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia
    • Osteoporosis Center of Armenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

3

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	Dietary supplement: Vitamin D3 (Cholecalciferol); 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	Dietary supplement: Vitamin D3 (Cholecalciferol); 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	Dietary supplement: Vitamin D3 (Cholecalciferol); 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	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	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: Columbia University
• Collaborators: Osteoporosis Center of Armenia
• Investigators: Principal Investigator: John Bilezikian, MD, Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Vitamin D repletion
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D; Cholecalciferol
• Other Study ID Numbers: AAAT5256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No