Vitamin D fortified milk supplementation in school childre
- Registration Number
- CTRI/2012/02/002429
- Lead Sponsor
- DSM Nutritional Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 780
Subjects in the age group of 10-14 years.
Subjects will be excluded from the study if they
•Have past or current history of renal stones
•Are taking or had taken vitamin D supplementation in last six months in doses exceeding 600 IU/day
•Have any systemic disease (cardiac, hepatic, endocrine or renal) or taking any kind of treatment
more than one month in last six months.
•Are diagnosed malabsorption (celiac disease, Crohnâ??s dis, ulcerative colitis) or history suggestive
of malabsorption especially history of milk allergy.
•Are using medications known to interact with vitamin D metabolism (steroids, thiazide diuretics,
phenytoin, phenobarbitone, and antitubercular drugs)
•Have known hypersensitivity to vitamin D preparation
•Have participated in any other investigational drug study in previous three months
•Have features suggestive of osteomalacia or severe vitamin D deficiency
•Are using Ultra-Violet (UV) radiations as a part of medical therapy
•Are diagnosed with albinism or have other condition associated with decreased skin pigmentation
•Have any medical condition that in the judgment of the investigator would jeopardize the
subjectâ??s safety or evaluation of study drug for efficacy or safety
•Have serum calcium more than 1 mg/dL above the upper limit of normal for age
•Have hypercalciuria as per definition
•Have serum 25-hydroxy vitamin D level more than 100 ng/mL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in vitamin D status as measured by serum 25-hydroxy vitamin D [S25(OH)D] levels.Timepoint: baseline and six months after supplementation
- Secondary Outcome Measures
Name Time Method To investigate the effects of vitamin D supplementation on serum alkaline phosphatase, parathyroid hormone (PTH) levels and insulin resistance.Timepoint: baseline and six months after supplementation