Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency

NCT06618365 | Active Not Recruiting DMC

• 1 other identifier: MRC-01-18-036
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this research is to find out if there is any difference between treating vitamin D deficiency with oral vitamin D3 or I.M vitamin D2. The second aim of this research is to confirm the superiority of Vitamin D3 over Vitamin D2 in treating vitamin D deficiency. Additional useful information in this research is to find out the best recommended maintenance dose of vitamin D and formula by having regular follow up of treated individuals once their serum vitamin D level reach the recommended normal serum level.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; Endocrinology

Outcome Measures

Primary Outcomes (1)

• Is oral Vitamin D3 superior to I.M Vitamin D2 in treating vitamin D deficiency?

  The primary outcome will be evaluated after 3 months from administration of the first dose for each subject to assess the serum level of vitamin D is attained. If a subject has reached normal Vitamin D serum level, they are qualified for phase 2 of the study.

  3 months from the administration of first dose

Secondary Outcomes (2)

• Confirming superiority of oral Vitamin D3 over oral Vitamin D2

  3 months after administration of the first dose.

• to compare the treatment of vitamin D deficiency by using intramuscular injection of vitamin D3 or Vitamin D2

  3 months after administration of the first dose.

Other Outcomes (1)

• evaluating recommended maintenance dose in certain time intervals of oral vitamin D3 and Vitamin D2

  24 weeks from initial baseline

Study Arms (4)

Group 1: Vitamin D2 50000 units per tablet

EXPERIMENTAL

They will take one tablet weekly.

Drug: Vitamin D Deficiency

Group 2: Vitamin D2 300000 units Intramuscular injection

EXPERIMENTAL

They will have one injection every 6 weeks initially.

Drug: Vitamin D Deficiency

Group 3: Vitamin D3 50000 units tablet

EXPERIMENTAL

They will take one tablet weekly.

Drug: Vitamin D Deficiency

Group 4: Vitamin D3 300000 units Intramuscular injection

EXPERIMENTAL

They will have one injection every 6 weeks initially.

Drug: Vitamin D Deficiency

Interventions

Vitamin D Deficiency DRUG

The first phase will involve studying 4 groups with the outcome (percentage of patients attaining Vitamin D levels \>30ng/ml) at 3 months to show the superiority of any of the groups. Vitamin D levels will be checked at baseline then 6 and 12 weeks. The second phase will include only patients who achieve the target level above 30ng/ml after the first phase and will be randomized to receive either oral Vitamin D2 or oral Vitamin D3 every 2, 3 or 4 weeks for another 3 months. For patients that achieved normal level in phase 1, we will keep a maintenance dose of the oral Vitamin D for 2 groups with 3 sub-groups under each.

Group 1: Vitamin D2 50000 units per tablet; Group 2: Vitamin D2 300000 units Intramuscular injection; Group 3: Vitamin D3 50000 units tablet; Group 4: Vitamin D3 300000 units Intramuscular injection

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-50 years
• Basal Vit D level should be between 10-18 ng/ml for phase 1 and between 30-50 ng/ml for phase 2

You may not qualify if:

• Pregnant Women
• history of renal implant or renal impairment of eGFR less than 60%
• Abnormal Liver function test
• patients with inflammatory bowel disease or of history of bariatric surgery

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: prospective randomized intervention using open label randomization.

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: October 1, 2024
• Study Start: February 2, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)