Hepcidin and Iron in Global Health (HIGH)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2014
INTERVENTION: The participants will be randomly assigned (1:1:1 ratio) to either receive: 1. MNP containing 12 mg/day iron 2. MNP containing 12 mg/day iron or 0 mg/day iron based on a weekly hepcidin screening indicating if iron can be given for the next 7 days or not 3. MNP containing 6 mg/day iron or 0 mg/day iron based on a weekly hepcidin screening indicating if iron can be given for the next 7 days or not Intervention product The nutritional supplement to be used in this trial is a micronutrient powder (MNP) (MixMe WHO) also distributed by UNICEF and WFP. The MNP contains 15 micronutrients. Three investigational products containing different quantities of iron will be administered: 1. MNP with 12 mg iron 2. MNP with 6 mg iron 3. MNP with 0 mg iron CONDITION: Anaemia ; Haematological Disorders ; Iron deficiency anaemia PRIMARY OUTCOME: Haemoglobin concentration at study day 84 SECONDARY OUTCOME: 1. Proportion of anaemia at study day 84 ; 2. Proportion of iron deficiency at day 84; 3. Proportion of iron deficiency anaemia at day 84; 4. Iron dosage; 5. Morbidity; 6. Safety; 7. Amount of iron absorbed over the supplementation period INCLUSION CRITERIA: 1. Apparently healthy 2. Age: 6 to 23 months 3. Not severely malnourished (HAZ, WAZ >‐3 SD and WHZ > ‐2 SD) 4. Hb = 7 g/dL and < 11 g/dL 5. Free of malaria 6. Resident in the study area 7. Ability and willingness to comply with the study protocol (weekly study visits with finger prick blood sampling) 8. Informed consent given by parent or guardian
Epistemonikos ID: e964433647ca9de53f3da5d5b1cb501831d24491
First added on: Aug 23, 2024