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NCT Number: NCT06618365

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamad Medical Corporation

Doha, 3050, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 3 months from the administration of first dose

    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.

Secondary outcomes

  1. Confirming superiority of oral Vitamin D3 over oral Vitamin D2

    Time frame: 3 months after administration of the first dose.

    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.

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

    Time frame: 3 months after administration of the first dose.

    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.

Other outcomes

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

    Time frame: 24 weeks from initial baseline

    The fourth outcome of evaluating recommended maintenance dose in certain time intervals of oral vitamin D3 and Vitamin D2.

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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