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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D Deficiency

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar, 3050
    • Hamad Medical Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Vitamin D2 50000 units per tablet; They will take one tablet weekly.	Drug: 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.
Experimental: Group 2: Vitamin D2 300000 units Intramuscular injection; They will have one injection every 6 weeks initially.	Drug: 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.
Experimental: Group 3: Vitamin D3 50000 units tablet; They will take one tablet weekly.	Drug: 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.
Experimental: Group 4: Vitamin D3 300000 units Intramuscular injection; They will have one injection every 6 weeks initially.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirming superiority of oral Vitamin D3 over oral Vitamin D2	The secondary outcome of confirming the superiority of oral Vitamin D3 over oral Vitamin D2 in treating vitamin D deficiency will be evaluated after a subject has completed 3 months since the administration of the first dose.	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	The third outcome also to compare the treatment of vitamin D deficiency by using intramuscular injection of vitamin D3 or Vitamin D2 and establish if there is any treatment is superior to another if we are using the intramuscular injections.	3 months after administration of the first dose.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluating recommended maintenance dose in certain time intervals of oral vitamin D3 and Vitamin D2	The fourth outcome of evaluating recommended maintenance dose in certain time intervals of oral vitamin D3 and Vitamin D2.	24 weeks from initial baseline

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 8, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D; Endocrinology
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: MRC-01-18-036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This was not intended initially, and the consent form does not include any clause for the participants to request sharing their data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No