Tata: Study of Vitamin D Fortification of Milk and Oil
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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. Exclusions will be as for the test group.
Inclusion Criteria: A subject will be considered eligible for inclusion in this study only if
ALL of the following 8 criteria apply:
-
Age between 5- 18 years, 18- 50 years and more than 50 years at the time of enrolment.
-
Intention to stay in the city for the next two years.
-
Families willing to continue with same brand of oil and milk for next two years after enrolment.
-
Children living with their biological mothers/parents.
-
Families willing to sign a consent form. Exclusion criteria: A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
-
History of illness involving calcium or bone metabolism, including stones of the urinary tract. 2. Currently taking vitamin D supplements as treatment of any disease. 3. Receiving immunosuppressive therapy (oral corticosteroids, chemotherapy) during the previous year. 4. Known history of lactose intolerance or other contra-indications or aversion to milk intake.
-
Known hypercalcemia or hypercalciuria. 6. Diabetes mellitus or past/current history of renal stones, and any known systemic, endocrine or metabolic disorder. 7. Medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs) 8. Hypersensitivity or allergy to any of the components used in non-fortified or fortified milk or oil. 9. Any other reason which in the opinion of a Principal Investigator would interfere with the study shall be excluded.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fortified Arm Individuals from families who are consume fortified milk + oil |
|
| Unfortified Arm families habitually consuming unfortified milk and oil |
Outcome Measures
Primary Outcome Measures
- To assess impact on serum 25OHD concentrations [After December 2022]
Effect of consumption of fortified versus unfortified milk and oil on serum 25OHD concentrations of participants
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Age between 5 to 80 years at the time of enrolment. 2. Intention to stay in the city for the next two years. 3. Families willing to continue with same brand of oil and milk for next two years after enrolment. 4. Children living with their biological mothers/parents. 5. Families willing to sign a consent form.
Exclusion Criteria:
-
- History of illness involving calcium or bone metabolism, including stones of the urinary tract. 2. Currently taking vitamin D supplements as treatment of any disease. 3. Receiving immunosuppressive therapy (oral corticosteroids, chemotherapy) during the previous year. 4. Known history of lactose intolerance or other contra-indications or aversion to milk intake. 5. Known hypercalcemia or hypercalciuria. 6. Diabetes mellitus or past/current history of renal stones, and any known systemic, endocrine or metabolic disorder. 7. Medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs) 8. Hypersensitivity or allergy to any of the components used in nonfortified or fortified milk or oil.
- Any other reason which in the opinion of a Principal Investigator would interfere with the study shall be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hirabai Cowasji Jehangir Medical Research Institute | Pune | Maharashtra | India | 411001 |
Sponsors and Collaborators
- Dr. Anuradha Khadilkar
- TATA Trusts
Investigators
- Study Director: Ravindra B. Ghooi, Ph.D., Scientia clinical services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TVDFT