Clinical trial NCT06618365: Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency
Official title: Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Endocrinology
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized intervention using open label randomization.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Is oral Vitamin D3 superior to I.M Vitamin D2 in treating vitamin D deficiency?
timeFrame: 3 months from the administration of first dose
Secondary outcomes:
measure: Confirming superiority of oral Vitamin D3 over oral Vitamin D2
timeFrame: 3 months after administration of the first dose.
measure: to compare the treatment of vitamin D deficiency by using intramuscular injection of vitamin D3 or Vitamin D2
timeFrame: 3 months after administration of the first dose.
Other outcomes:
measure: evaluating recommended maintenance dose in certain time intervals of oral vitamin D3 and Vitamin D2
timeFrame: 24 weeks from initial baseline
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
References: