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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063141

Enrollment

Registered

2024-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Intervention1: •Arm A (30 subjects): Oral Vitamin D3 granules : Oral Vitamin D3 granules (60000IU) every week Intervention2: •Arm B (30 subjects): Oral Vitamin D3 softgels: Oral Vitamin D3 softgels (

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Weekly change in vitamin D3 levels up to 1 month Timepoint: 3 Months	—

Secondary

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

Countries

India

Contacts

Public ContactDr Sunil Chaudhary

Alkem Laboratories Ltd

roshan.pawar@alkem.com9970849872

Outcome results