None listed
Conditions
Interventions
Intervention1: Double Fortified Salt plus Vitamin B12: Salt fortified with iodine (potassium iodate 30 ppm), microencapsulated iron (ferrous fumarate 1100 ppm elemental iron), and vitamin B12 (cyanoco
Sponsors
Cornell University
Eligibility
Inclusion criteria
Inclusion criteria: Early adolescent girls (10-14 years), women of reproductive age group (15-49 years) and women aged 50 years and above Healthy (defined further below under exclusion criteria) Not pregnant or lactating Plan to reside within the study area for at least two years.
Exclusion criteria
Exclusion criteria: Severe anaemia (Haemoglobin less than 8.0 g/dL) Reported diagnosis of HIV, malaria infection, or active tuberculosis disease Malabsorption disorders (e.g., inflammatory bowel disease; i.e., medical conditions that may affect vitamin B12 absorption or metabolism) Stage 2 hypertension (i.e., systolic blood pressure (SBP) more than equal to 140 mm Hg or diastolic blood pressure (DBP) more than equal to 90 mm Hg) Glycated haemoglobin (HbA1c) more than equal to 6.5% Other serious pre-existing medical conditions (i.e., defined as the need for regular medication use), including diabetes, chronic kidney disease, cardiovascular disease, and thyroid disease Active infections or acute illnesses (e.g., fever, malaria, dengue, blood in stool) Previous pregnancy affected by a neural tube defect (i.e., who have had a foetus diagnosed as affected by a neural tube defect or have given birth to a baby with a neural tube defect) (will be referred to OB/GYN for standard of care, including folic acid supplementation, and excluded) Planning to become pregnant (or planning to have a child) in the next 12 months (will be referred to OB/GYN for standard of care, including folic acid supplementation, and be excluded) Taking daily (more than or equal to 4 times in the past week) micronutrient supplements (i.e., tablets, capsules, dispersible tablets) Received an intramuscular or intravenous intervention containing medications or micronutrients (e.g., iron, vitamin B12, folic acid) in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in haemoglobin concentration (g/dL), red blood cell folate concentration (nmol/L), and serum total vitamin B12 concentration (pmol/L) among early adolescent girls (10-14 years), Women of Reproductive age group (15-49 years) and women aged 50 years and above in Southern India.Timepoint: Baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of anaemiaTimepoint: Baseline and 12 months;Prevalence of folate deficiency and folate insufficiency among women of reproductive age (15-49 years).Timepoint: Baseline and 12 months;Prevalence of vitamin B12 among women of reproductive age (15-49 years).Timepoint: Baseline and 12 months | — |
Countries
India
Contacts
Public ContactDr N Samarasimha Reddy
ICMR- National Institute of Nutrition
Outcome results
None listed