Evaluation of efficacy and safety of various doses of oral vitamin D required to achieve optimal serum level of Vitamin D among Indian adults
- Registration Number
- CTRI/2019/01/016855
- Lead Sponsor
- Intramural Research grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
All the subjects of 18- 60 years of age who will be willing to give written consent for their participation in the study
1.Accident or surgery in last 6 weeks.
2.Known TB, sarcoidosis or another granulomatous disease.
3.Known chronic sickness- kidney/liver/lung/bone/muscle/ heart disease/ malabsorption/ stroke.
4.Diabetes mellitus/ Thyroid/ parathyroid/adrenal/pituitary disease.
5.Cancers on treatment or treated within last 1 year.
6. Known autoimmune disorders or rheumatologic illnesses.
7. Pregnancy and lactation in last 6 months
8. History of any hereditary or aquired disorder related to calcium metabolism.
9.History of any drug intake that affects calcium or vitamin D metabolism (Steroids, Lithium, Rifampicin, Isoniazid, Ketoconazole, Statins, Aluminium hydroxide, Barbiturates, Phenytoin, Valproate, Cholestyramine, Cholestipol, Thiazide etc.)
10.History of intake of calcium or vitamin D supplements in last 3 months before enrolment.
11.History of parenteral vitamin D administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To identify the optimal oral dose of Vitamin D (daily vs monthly) to bring and maintain serum 25(OH)D levels in the target range (20-30ng/dl) among India adults. <br/ ><br>2.To evaluate the impact of VD supplemetation on serum parathyroid hormone and bone mineral parameters <br/ ><br>Timepoint: Baseline, 12 weeks post supplementation, post washout phase (24 weeks) and 36 weeks post supplementation.
- Secondary Outcome Measures
Name Time Method 1.To evaluate any non-skeletal benefits of VD supplementation and subsequent normalization of serum 25(OH)D in ameliorating abnormal glucose tolerance, insulin resistance and hypertension.Timepoint: Baseline, 12 weeks post supplementation, post washout phase (24 weeks) and 36 weeks post supplementation.