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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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4 November 2019 |
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Main ID: |
ISRCTN21955180 |
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Date of registration:
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14/04/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hepcidin and Anaemia in Pregnancy (HAPn)
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Scientific title:
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A double-blind randomised controlled trial comparing standard dose of iron supplementation for pregnant women with two screen-and-treat approaches using hepcidin as a biomarker for ready and safe to receive iron |
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Date of first enrolment:
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21/04/2014 |
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Target sample size:
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462 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN21955180 |
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Study type:
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Interventional |
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Study design:
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Proof-of-concept three-arm double-blind randomised controlled trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Gambia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Amat
Bah |
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Address:
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MRC International Nutrition Group
MRC Keneba
POBOX 273
Banjul
Gambia |
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Telephone:
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+220 9901696 |
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Email:
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Amat.Bah@lshtm.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Pregnant (gestational age between 14 - 22 weeks)
2. Age: 18 to 45 years
3. Likely to be resident in study area for duration of trial
4. Written informed consent obtained
Exclusion criteria:
1. Severely anaemic (< 7 g/dl)
2. Seriously ill (infectious disease of clinical significance) at recruitment
3. Chronic disease
4. Pregnancy complications (e.g. pre-eclampsia) at enrolment
5. Already part of another study
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anaemia in pregnancy
Pregnancy and Childbirth
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Intervention(s)
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This study will involve 462 pregnant women between 14 and 22 weeks gestation over a period of 12 weeks randomly assigned (1:1:1 ratio) to either receive:
1. UNIMMAP containing 60 mg/day iron
2. UNIMMAP containing 60 mg/day iron but based on a weekly hepcidin screening indicating if iron can be given for the next 7 days or not
3. UNIMMAP containing 30 mg/day iron
Intervention product
The nutritional supplement to be used in this trial is the UNICEF/WHO/UNU international multiple micronutrient preparation (UNIMMAP). All formulations also contain 400 ug folic acid and 14 other micronutrients. Three investigational products will be administered:
UNIMMAP with 60 mg iron
UNIMMAP with 30 mg iron
UNIMMAP with 0 mg iron (for when iron is not needed).
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Primary Outcome(s)
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Haemoglobin - defined as pregnancy stage adjusted haemoglobin at day 84
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Secondary Outcome(s)
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1. Proportion of anaemia (Hb < 11 g/dl) at day 84
2. Iron deficiency prevalence at day 84
3. Iron deficiency anaemia (IDA) prevalence at day 84
4. Iron dosage
5. Beneficial and adverse events
6. Compliance
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Secondary ID(s)
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SCC 1357v3
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK) - International Nutrition Group, Bill & Melinda Gates Foundation (USA)
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Ethics review
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Status:
Approval date:
Contact:
The Gambia Government/MRC Joint Ethics Committee, 19/12/2013, ref. SCC 1357v3
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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21/03/2015 |
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URL:
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