NCT05541094

Study of Vitamin D Fortification of Milk and Oil

Impact of Vitamin D Fortification of Milk and Oil on Serum Vitamin D Concentrations - An Effectiveness Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 448 (actual)
• Sponsor: Dr. Anuradha Khadilkar · Academic / Other
• Sex: All
• Age: 5 Years – 80 Years
• Healthy volunteers: Accepted

Summary

It is a two-year longitudinal effectiveness study. A comparative study with a case-control design. Study will be conducted in Pune city. A total of up to 100 families (50 families per group) will be recruited. The test group will consist of families consuming fortified milk and oil and the control group will consist of families consuming non fortified milk and oil. Individuals between the age 5-18 years, 18-50 years and more than 50 years will be enrolled. Families which intend to stay in the city for the next 2 years, willing to continue with the same brand of milk and oil for the next 2 years, children living with their biological parents and families willing to sign consent form, will be enrolled in the study. Individuals having chronic illnesses likely to affect vitamin D concentrations and those allergic to milk will be excluded.

Detailed description

Study design: A two-year longitudinal effectiveness study Sample selection: Hundred families will be selected for this study, 50 in each group. For the test group, people/families buying the standardized milk habitually will be identified and offered the study, an ethics approval would be obtained before commencing the study. After a consent is signed, a home visit will be made and family will be given information about the study. Individuals from families who consume standardized fortified milk + fortified oil will be offered the study. The control group will consist of families consuming unfortified milk and oil. Thus, families habitually consuming unfortified milk and oil (from 'ghanas') will be offered the study.

Conditions

• Healthy Individuals

Timeline

• Start date: 2020-10-13
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-09-15
• Last updated: 2023-03-22

Locations

1 site across 1 country: India