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

Hamad Medical Corporation (HMC)

Status: Active, not recruiting

Conditions: Vitamin D Deficiency

Treatments: Drug: Vitamin D Deficiency

Study type: Interventional

Funder types: Industry

Identifiers

NCT06618365

MRC-01-18-036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 4 patient groups

Group 1: Vitamin D2 50000 units per tablet

Experimental group

Description:

They will take one tablet weekly.

Treatment:

Drug: Vitamin D Deficiency

Group 2: Vitamin D2 300000 units Intramuscular injection

Experimental group

Description:

They will have one injection every 6 weeks initially.

Treatment:

Drug: Vitamin D Deficiency

Group 3: Vitamin D3 50000 units tablet

Experimental group

Description:

They will take one tablet weekly.

Treatment:

Drug: Vitamin D Deficiency

Group 4: Vitamin D3 300000 units Intramuscular injection

Experimental group

Description:

They will have one injection every 6 weeks initially.

Treatment:

Drug: Vitamin D Deficiency