Milk fortification with Vitamin D in school chidlre
- Registration Number
- CTRI/2019/09/021073
- Lead Sponsor
- Society for endocrine health care in elderly adolescents and children
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Healthy school going children
1. Have past or current history of renal stones
2. Are taking or had taken vitamin D supplementation in last six months in doses exceeding 600 IU/day
3. Have any systemic disease (cardiac, hepatic, endocrine or renal) or taking any kind of treatment more than one month in last six months.
4. Are diagnosed with malabsorption or history of milk allergy.
5. Are using medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs)
6. Have participated in any other investigational drug study in previous three months
7. Have features suggestive of osteomalacia or severe vitamin D deficiency (serum 25(OH)D <12 ng/mL) which will necessitate treatment with vitamin D
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum 25 hydroxy Vitamin DTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Serum calcium, phosphate, alkaline phosphatase, parathyroid hormone <br/ ><br>Bone markers serum C-terminal telopeptide of type I collagen (CTX-I) and N-terminal propeptide of type I procollagen (PINP)Timepoint: Three months