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

NCT06406543 | Completed

• 1 other identifier: AAAT5256
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D repletion

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

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

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

Dietary Supplement: Vitamin D3 (Cholecalciferol)

Interventions

Vitamin D3 (Cholecalciferol) DIETARY_SUPPLEMENT

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

High dose, low frequency vitamin D repletion; Low dose, high frequency vitamin D repletion; Medium dose, medial frequency vitamin D repletion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Osteoporosis Center of Armenia: collaborator

Study Sites (1)

Osteoporosis Center of Armenia

Yerevan, Armenia

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• John Bilezikian, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 9, 2024
• Study Start: December 1, 2023
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)