Evaluation of the efficacy and safety of the three different Vitamin D formulations in VIT-D3 deficient subjects.

Phase 4

Completed

• Registration Number: CTRI/2018/12/016539
• Lead Sponsor: Zim Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-10-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

1.Subject between age of 18 to 65 (both inclusive).

2.Subjects who are willing and able to take part and attend all required clinical trial visits, able to understand the information given to them and give written consent.

3.Subject having blood 25 OH-Vitamin D3 level of Ë?20 ng/ml.

Exclusion Criteria

1.Creatinine level >=1.9.

2.History of hyperparathyroidism, a known risk factor for hyperkalemia.

3.History of nephrolithiasis given that hypervitaminosis D can increase the risk of nephrolithiasis.

4.Current use of any dose of glucocorticoids, a known risk factor for hypercalcuria.

5.History of sarcoidosis, tuberculosis, or Paget disease which are known risk factors for hypercalcemia.

6.History of Vitamin D intoxication and Granulomatous diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy end point: End points will be assessed against the level of 25(OH)D3 <br/ ><br>â?¢Comparison of three treatment options using 25(OH)D3 level. <br/ ><br>â?¢Normalization rate of 25(OH)D3 at each visit <br/ ><br>â?¢Mean dose changes among three different groups of vitamin D3 treatment through day 120.Timepoint: Baseline, 60 days, 90 days and 120 days

Secondary Outcome Measures

Name	Time	Method
Safety end points <br/ ><br>â?¢No. of Adverse events <br/ ><br>â?¢Severity of adverse event <br/ ><br>â?¢ ConvenienceTimepoint: 120 Days