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

NCT ID: NCT06618365

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2025-12-31

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.

Detailed Description

In a systemic review, it was found that treating individuals who have vitamin D deficiency with vitamin D3 rather than vitamin D2 would be a better option. Vitamin D3 is superior in treating Vitamin D deficiency according to this systemic review. However, this systemic review raised a question of comparing oral to I.M treatment of vitamin D deficiency and no Data was available to support either treatment above the other.

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.

The research will involve 100 patients between the age of 20-50 years old. They will be divided into 4 groups. Each group will have either oral or I.M vitamin D2 or oral or I.M vitamin D3. The oral doses will be 50000 international units to be taken weekly and the I.M doses will be of 300000 international units which will be taken once every 6 weeks. Vitamin D level will be checked once every 4 weeks. The initial expected duration of the first phase of the research will be about 6-12 weeks which will give us a good orientation to answer the main and the second questions. Then the follow up may take up to another 6 months to check the maintenance dose of the best recommended oral or I.M treatment of bolus doses in certain intervals as initial trial.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1: Vitamin D2 50000 units per tablet

They will take one tablet weekly.

Group Type: EXPERIMENTAL

Vitamin D Deficiency

Intervention Type: 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 2: Vitamin D2 300000 units Intramuscular injection

They will have one injection every 6 weeks initially.

Group Type: EXPERIMENTAL

Vitamin D Deficiency

Intervention Type: 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 3: Vitamin D3 50000 units tablet

They will take one tablet weekly.

Group Type: EXPERIMENTAL

Vitamin D Deficiency

Intervention Type: 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 4: Vitamin D3 300000 units Intramuscular injection

They will have one injection every 6 weeks initially.

Group Type: EXPERIMENTAL

Vitamin D Deficiency

Intervention Type: 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.

Interventions

Vitamin D Deficiency

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr Hassan Saqr

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hamad Medical Corporation

Doha, , Qatar

Countries

Qatar

Other Identifiers

MRC-01-18-036

Identifier Type: -

Identifier Source: org_study_id