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Hepcidin and Iron in Global Health (HIGH)

Efficacy and safety of hepcidin-based screen-and-treat approaches using two different doses vs a standard universal approach of iron supplementation in young children in rural Gambia: a double-blind randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN07210906
Enrollment
393
Registered
2014-07-16
Start date
2014-05-26
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia Haematological Disorders Iron deficiency anaemia

Interventions

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

Sponsors

Medical Research Council (MRC) (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Congenital disorders 2. Chronic disease 3. Regular medication 4. Currently participating in another study

Design outcomes

Primary

MeasureTime frame
Haemoglobin concentration at study day 84

Secondary

MeasureTime frame
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

Countries

Gambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026