None listed
Conditions
Interventions
Intervention1: Prospective cohort: A stable isotope of iron, such as 57Fe is administered orally as part of a ferrous salt. Oral iron will be administered as ferrous sulphate syrup administered under
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Prospective cohort - a. Healthy infants of both sexes aged 6 to 8 months (inclusive of both limits) b. Birth weight of 2 kg or more c. Weight for length Z score (more than or equal to minus 2) d. Parents staying in the study area for the next 2 years Randomised controlled study - a. Healthy children of both sexes aged 9 to 23 months b. Hemoglobin more than or equal to 7 g per dL and less than 10.5gm per dL c. Serum ferritin less than 12 microgram per L d. Weight for length Z score more than or equal to minus 2 at baseline e. Birth weight 2 kg or more f. Parents willing to reside in the study area during participation in the study
Exclusion criteria
Exclusion criteria: Prospective cohort: 1. Major congenital anomaly 2. Consumption of iron supplements by child in the previous 3 months 3. Any significant medical or surgical history 4. History of hospitalization in the past 3 months 5. Not wiling for a written informed consent Randomised controlled study: 1. Children with severe anemia (Hb less than 7 g per dL) at baseline 2. Children who have received oral or parenteral iron supplements in the previous two weeks 3. Anemia due to non-nutritional causes chronic renal failure, hemoglobinopathies, inflammatory bowel disease, etc 4. Children with any known major medical or surgical disorder 5. Children with major congenital anomalies 6. Children with known gastrointestinal disease, which is likely to affect absorption of oral iron 7. Parents not willing to provide written informed consent 8. Ongoing episode of acute or chronic infection (temporary exclusion criterion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prospective cohort: 1. Changes in the total body iron (Fetot) and hemoglobin between day 0 and days 42 and 84 2. Iron loss (Feloss), absorption (Feabs) and net gain (Fegain) between days 0 and day 42 and 84 Randomised controlled study: Proportion of non-anaemic (Hb more than or equal to 10.5 gm per dL for children less than or equal to 23 months and Hb more than or equal to 11 gm per dL for children more than or equal to 24 months and iron-replete (Hb more than or equal to 10.5 gm per dL for children less than or equal to 23 months and Hb more than or equal to 11 gm per dL for children more than or equal to 24 months and serum ferritin more than 12 microgram per L) participants on day 84Timepoint: At the end of 84 days of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Randomised controlled study: - Mean change seen in hemoglobin levels on day 84 as compared to baseline - Mean change seen in ferritin levels on day 84 as compared to baseline - Response to OIS in children with low hepcidin as compared to high hepcidin (in subsample) - Gastrointestinal and other adverse events experienced by the participants during the study - Extent of adherence to biweekly OIS as compared to daily OIS Comparison of the gut microbiome profile at baseline and on day 84, in terms of abundance patterns of bacterial genera, using gene sequencing and quantitation of bacterial species (log number of gene copies per gm of faeces), using qPCR. - Comparison of changes in the gut microbiome profile after daily and biweekly OIS.Timepoint: At the end of 84 days of intervention | — |
Countries
India
Contacts
Public ContactDr Aditi Apte
Vadu Rural Health Program and Community Health Research Unit , KEM Hospital Research Centre, Pune
Outcome results
None listed