Comparative Evaluation of Three Vitamin D3 Formulations for Sequential Improvement of Vitamin D3 Levels throughout a period of 3-Months.

Phase 4

Registration Number: CTRI/2024/02/063141

Lead Sponsor: Dr Roshan Pawar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Willing to provide voluntary written informed consent.

2.If an individual is unable to provide informed consent due to reasons such as illiteracy, a Legal Authorized Representative (LAR) will be required to provide written informed consent.

3.Male or Female subjects between 18 to 65 years of age (both inclusive)

4.Vitamin D3 deficiency less than 20 ng/ml

5.Willing and able to comply with the protocol.

Exclusion Criteria

1.Any Surgery or hospitalization within 28 days before enrolment

2.Known hypersensitivity to any component of the investigational product and other medications used in this study

3.Patients already on supplementation of calcium and/or Vitamin D

4.Patients suffering from acute or chronic infection(s)

5.BMI greater than 40 Kg/m2

6.Female patients who are pregnant or nursing

7.Patients with H/O concurrent disease or conditions like ESRD, pre-existing liver cell failure, terminally ill cancer or critically ill patients, which in the opinion of the investigator does not allow participation of the patient in this study

8.Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weekly change in vitamin D3 levels up to 1 month <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 3 Months <br/ ><br> <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Total improvement of vitamin D3 levels over the period of 3 months <br/ ><br>2.Percentage of people achieving optimal Vitamin D level at week 4,8 and week 12 in 3 groups. <br/ ><br>3.Incidence of TEAEs <br/ ><br>4. Monthly change in vitamin D3 levels after 3 months in 20 patients (Sub-study) <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 3 Months