Micronutrient deficiency in Developmental Origins of Health and Disease (DOHaD) Nutritional, Metabolic, Endocrine Micronutrient deficiency
Conditions
Interventions
Each participant will be given one of the following six medications, to be taken orally, one capsule per day for a period of 12 months:
1. Folic acid, 0 µg and vitamin B12, 0 µg (placebo)
2. Folic aci
Sponsors
King Edward Memorial (KEM) Hospital and Research Centre (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Parents and children belonging to a subset of the Pune Maternal Nutrition Study cohort consenting for participation.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of vitamin B12, folate, tHcy, and MMA, measured at the end of four months and twelve months of supplementation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Haemogram 2. Blood glucose 3. Lipid profile 4. Serum creatinine 5. Insulin levels 6. Body composition (anthropometry, Dual Energy X-ray Absorptiometry [DEXA])* 7. Blood pressure 8. Grip-strength* 9. Neuro-cognitive performance* 10. Arterial elasticity* 11. Food Frequency Questionnaire (FFQ)* (* These will be measured only in children). All secondary outcomes to be measured at the end of 12 months of supplementation. | — |
Countries
India
Outcome results
None listed