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Register:	ISRCTN
Last refreshed on:	9 January 2023
Main ID:	ISRCTN07210906
Date of registration:	16/07/2014
Prospective Registration:	No
Primary sponsor:	Medical Research Council (MRC) (UK)
Public title:	Hepcidin and Iron in Global Health (HIGH)
Scientific title:	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
Date of first enrolment:	26/05/2014
Target sample size:	393
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN07210906
Study type:	Interventional
Study design:	Proof-of-concept three-arm double-blind randomised controlled trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Gambia

Contacts

Name:	Rita Wegmüller
Address:	Head of Station, MRC Keneba MRC International Nutrition Group MRC Keneba MRC Unit, The Gambia PO Box 273 Banjul Gambia
Telephone:	-
Email:	rwegmuller@mrc.gm
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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:
1. Congenital disorders
2. Chronic disease
3. Regular medication
4. Currently participating in another study

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Anaemia
Haematological Disorders
Iron deficiency anaemia

Intervention(s)

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

Primary Outcome(s)

Haemoglobin concentration at study day 84

Secondary Outcome(s)

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

Secondary ID(s)

SCC 1358 Version 1

Source(s) of Monetary Support

Medical Research Council, Bill and Melinda Gates Foundation

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

The Gambia Government/MRC Joint Ethics Committee, 19/12/2013, ref. SCC 1358v1

Results

Results available:	Yes
Date Posted:
Date Completed:	30/11/2015
URL:

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