Study of Vitamin D Fortification of Milk and Oil
Tata
Impact of Vitamin D Fortification of Milk and Oil on Serum Vitamin D Concentrations - An Effectiveness Study
1 other identifier
observational
448
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2020
CompletedFirst Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 22, 2023
March 1, 2023
2.2 years
September 12, 2022
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
To assess impact on serum 25OHD concentrations
Effect of consumption of fortified versus unfortified milk and oil on serum 25OHD concentrations of participants
After December 2022
Study Arms (2)
Fortified Arm
Individuals from families who are consume fortified milk + oil
Unfortified Arm
families habitually consuming unfortified milk and oil
Eligibility Criteria
Individuals between the age 5 - 80 years will be enrolled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Anuradha Khadilkarlead
- TATA Trustscollaborator
Study Sites (1)
Hirabai Cowasji Jehangir Medical Research Institute
Pune, Maharashtra, 411001, India
Related Publications (1)
Mandlik R, Deshpande S, Ladkat D, Patwardhan V, Khadilkar A. Impact of consumption of vitamin D fortified foods on serum vitamin D concentrations and vitamin D status in families living in Pune, India: an effectiveness study. Eur J Nutr. 2025 Mar 1;64(2):105. doi: 10.1007/s00394-025-03624-x.
PMID: 40025346DERIVED
Study Officials
- STUDY DIRECTOR
Ravindra B. Ghooi, Ph.D.
Scientia clinical services
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy Director at HCJMRI Pune
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 15, 2022
Study Start
October 13, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 22, 2023
Record last verified: 2023-03