Can developmental programming of adiposity and insulin resistance in rural Indian children be reversed during adolescent growth by vitamin B12 supplementation? A pilot study
Completed
- Conditions
- Micronutrient deficiency in Developmental Origins of Health and Disease (DOHaD)Nutritional, Metabolic, EndocrineMicronutrient deficiency
- Registration Number
- ISRCTN59289820
- Lead Sponsor
- King Edward Memorial (KEM) Hospital and Research Centre (India)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
Parents and children belonging to a subset of the Pune Maternal Nutrition Study cohort consenting for participation.
Exclusion Criteria
1. Refusal to participate
2. Not available to complete the study for 12 months
3. Haemoglobin below lower limit of normal for sex and age, requiring treatment with iron and folic acid, vitamin B12, or both
4. Need to take drugs known to impair the absorption or utilisation of folic acid and vitamin B12, e.g., some antiepileptics
5. Women of child bearing age will be excluded if becoming pregnant
6. Individuals who are taking folic acid and/or vitamin B12 supplements since ten or more days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum levels of vitamin B12, folate, tHcy, and MMA, measured at the end of four months and twelve months of supplementation.
- Secondary Outcome Measures
Name Time Method 1. Haemogram<br>2. Blood glucose<br>3. Lipid profile<br>4. Serum creatinine<br>5. Insulin levels<br>6. Body composition (anthropometry, Dual Energy X-ray Absorptiometry [DEXA])*<br>7. Blood pressure<br>8. Grip-strength*<br>9. Neuro-cognitive performance*<br>10. Arterial elasticity*<br>11. Food Frequency Questionnaire (FFQ)*<br><br>(* These will be measured only in children). All secondary outcomes to be measured at the end of 12 months of supplementation.