Vitamin D injection versus oral vitamin D in adults with vitamin D deficiency
- Registration Number
- CTRI/2023/07/055517
- Lead Sponsor
- Cadila Pharmaceutical Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult, human subject aged from 18 to 65 years (inclusive both) with 25-hydroxyvitamin D [25(OH)D] < 30ng/mL.
2. Not taken any Vitamin D supplementation in last 30 days
3. Willing to sign written informed consent form
4. No contraindications with the study medication with any previous medical or surgical history.
1. Known history of hypersensitivity or idiosyncratic reaction to Cholecalciferol or any of its excipients
2. Known intake of heparin or other drugs that interfere with calcium metabolism.
3. Any psychiatric disorder, personality disorder, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study, or limit the ability to comply with protocol requirements
4. Any known medical illness (acute or chronic)
5. Pregnancy and lactation
6. Women intending to become pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum 25-hydroxyvitamin DTimepoint: 0, 4, 8, 12 weeks
- Secondary Outcome Measures
Name Time Method Safety evaluationTimepoint: 0, 4, 8, 12 weeks;Serum calciumTimepoint: 0, 4, 8, 12 weeks