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

A single centre, open label, prospective, randomized, parallel group, comparative study to evaluate efficacy and safety of three different form of Vitamin D repletion strategies with standard treatment (Calcium tablet) in VIT-D3 deficient subjects.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016539

Enrollment

Registered

2018-12-05

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: Finevit-D3: Vitamin D3 Orally disintegrating strip 60000 IU Control Intervention1: Calcirol: Vitamin D3 Granules 60000 IU/gm Control Intervention2: CoeD3: Vitamin D3 Oral Solution 60000

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Efficacy end point: End points will be assessed against the level of 25(OH)D3 â?¢ Comparison of three treatment options using 25(OH)D3 level. â?¢ Normalization rate of 25(OH)D3 at each visit 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

Measure	Time frame
Safety end points â?¢ No. of Adverse events â?¢ Severity of adverse event â?¢ ConvenienceTimepoint: 120 Days	—

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com09825585119

Outcome results