Health Condition 1: E559- Vitamin D deficiency, unspecified
Conditions
Interventions
Intervention1: Vitamin D3 600 IU: Oral food based Vitamin D3 (cholecalciferol) 600 IU supplement, taken as one capsule once daily for 90 days.
Control Intervention1: NIL: NIL
Sponsors
Gelnova Laboratories Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of either gender aged between 18 to 60 years (both inclusive). 2.Adult subjects with or without vitamin D deficiency having serum 25 hydroxyvitamin D levels in the range of 10 to 50 ng per mL at baseline investigation. Note: Serum 25 hydroxyvitamin D results obtained within 5 days prior to screening may also be considered for eligibility assessment. 3.Subjects willing to provide written informed consent and comply with the study protocol requirements. 4.Subjects willing to undergo blood sample collection (phlebotomy) for assessment of serum 25 hydroxyvitamin D, liver function tests, renal function tests, and hematological parameters as per the study schedule.
Exclusion criteria
Exclusion criteria: 1.Subjects currently receiving vitamin D, omega 3, or fish oil supplementation. 2.Subjects with known active medical conditions such as respiratory or gastrointestinal infections, diabetes mellitus, polycystic ovarian disease, history of bowel surgery, irritable bowel syndrome, or inflammatory bowel disease. 3.Subjects with epilepsy or currently receiving antiepileptic treatment. 4.Subjects receiving systemic steroid therapy within the last 4 weeks prior to screening. 5.Pregnant or lactating females, or female subjects of childbearing potential unwilling to undergo pregnancy testing where applicable. 6.Subjects with recent stroke or coronary event. 7.Subjects with current malignancy or undergoing cancer treatment within the past 12 months. 8.Subjects with body mass index more than 30 kg per square meter. 9.Subjects unable or unlikely to adhere to the study procedures, monitoring schedule, or follow up visits. 10.Subjects who are fasting or following dietary practices that may interfere with study assessments. 11.Participation in another clinical study within 4 weeks prior to screening. 12.Subjects with known hypercalcemia, hyperparathyroidism, severe renal impairment, severe hepatic disease, or other metabolic disorders affecting vitamin D metabolism. 13.Subjects with known hypersensitivity to vitamin D3 or any component of the study product. 14.Any other reason for which the investigator feels that the subject should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum 25 hydroxyvitamin D levels from baseline Day 0 to end of study Day 90 with a window period of plus minus 5 days following daily supplementation with oral Vitamin D3 cholecalciferol 600 IU.Timepoint: From Day 0 (Baseline) to Day 90 (End of Study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events reported during the study.Timepoint: From Day 0 (Baseline) to Day 90 (End of study).;Serious adverse events reported during the studyTimepoint: From Day 0 (Baseline) to Day 90 (End of study).;Withdrawals due to adverse events, if any.Timepoint: From Day 0 (Baseline) to Day 90 (End of study).;linically significant abnormalities in hematological and biochemical laboratory parameters including complete blood count, renal function tests, and liver function tests.Timepoint: From Day 0 (Baseline) to Day 90 (End of study).;Change in serum 25 hydroxyvitamin D levels.Timepoint: From Day 0 (Baseline) to Day 30 (Visit 2) and Day 60 (Visit 3).;Proportion of subjects achieving improvement or normalization of serum 25 hydroxyvitamin D levels.Timepoint: At Day 90 (End of study). | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Gelnova Laboratories Pvt. Ltd.
Outcome results
None listed