Evaluation of efficacy and safety of various doses of oral vitamin D required to achieve optimal serum level of Vitamin D among Indian adults

Evaluation of efficacy and safety of various doses of oral cholecalciferol required to achieve optimal serum level of 25(OH)D among adults.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/016855

Enrollment

120

Registered

2019-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: oral cholecalciferol: 600 IU daily for 12 weeks in phase I followed by a washout phase of 12 weeks and then again for 12 weeks in phase II. Intervention2: oral cholecalciferol: 1000 IU

Eligibility

Inclusion criteria

Inclusion criteria: All the subjects of 18- 60 years of age who will be willing to give written consent for their participation in the study

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. 2. To evaluate the impact of VD supplemetation on serum parathyroid hormone and bone mineral parameters Timepoint: Baseline, 12 weeks post supplementation, post washout phase (24 weeks) and 36 weeks post supplementation.	—

Secondary

Measure	Time frame
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.	—

Countries

India

Contacts

Public ContactDr Shivani

Sher-i-Kashmir Institute of Medical Sciences Soura, Srinagar

ashraf.endo@gmail.com1942405501

Outcome results