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Completed

NCT Number: NCT01208363

Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study

Rationale: Iron deficiency and zinc deficiency, are of public health significance in sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer from anaemia, half of which is estimated iron deficiency anaemia. Interventions have been designed and implemented over the years towards solving hunger and anaemia especially among school age children. One of such interventions is School Feeding Programme (SFP) which is common in both developing and industrialized countries. SFP has been part of the Ghanaian educational system for well over 40 years, albeit on small scale. The main stay of the programme that makes it distinguishable from other past and existing school feeding programmes is its reliance on locally produced and available foods, such as cowpeas. Legume staples like cowpea have been identified to be important sources of protein and non-heme iron to rural populations of developing countries like Ghana. The problem however is the low bioavailability of these micronutrients from these legumes.

Objective: To assess the efficacy of iron fortified cowpea based meal (Tubani) in improving iron status of primary school children in rural northern Ghana Study design: A randomized double blind parallel design will be conducted. One group will receive iron fortified Tubani with NaFeEDTA and the other group will receive unfortified Tubani.

Study population: Two hundred and forty apparently healthy pupils in lower primary school will participate. The participating schools have a school feeding programme currently in operation.

Intervention (if applicable): Children will be fed Tubani containing 10mg of fortification iron (in the form of NaFeEDTA) three times in a week for six months. Weight, height and blood samples will be measured at baseline and after six months of intervention. Participants will be treated against intestinal parasites before start of intervention and halfway through the intervention.

Main study parameters/endpoints: The main study endpoint is iron-deficiency anaemia (IDA). IDA will be defined as concurrent anaemia and iron deficiency. Whole blood will be collected for the analysis of Hb, serum ferritin (SF), serum transferring receptor (sTfR) and C-reactive protein (CRP). Anemia will be defined as a hemoglobin concentration <115 g/L, and iron deficiency will be defined as an SF concentration <12 µg/L.

Venipunctures occasionally lead to bruises or small local inflammation which usually disappear within one week. To minimize this risk, blood collection will be performed by a trained and experienced phlebotomists. Written informed consent will be obtained from all subjects.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Community Nutrition, University for Development Studies

Tamale, Ghana

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 6-12 years old
  • Regularly attending school, in grades 1-3
  • Apparently healthy, free of chronic illnesses and not taking chronic medication.
  • No medication nor supplemental iron at time of entry into the study
  • Informed consent obtained from at least one parent or guardian

Exclusion criteria

  • Children with severe anemia (Hb<70 g/l).

Treatment and study plan

Cowpea fortified with NaFeEDTA, in form of Toubani.

Dietary Supplement

66g raw Cowpea fortified with 10 mg Fe as NaFeEDTA, in form of Toubani, a cowpea snack. Ther snack will be given to the participants 3 times per week, for six month integrated in the school feeding trial.

Primary outcomes

  1. Iron deficiency anemia, defined by Hb<115 g/l; SF<12 microgram/l

    Time frame: Duration will be 6 months. Measurements will be performed at start and after 6 months of intervention.

    Autcome parameters are Hemoglobin (Hb), Serum Ferritin (SF), Serum Transferrin Receptor (sTfR), and C - Reactive protein (CRP). Prevalence of iron deficiency anemia will be calculated based on the umber of subjects with Hb<115 g/l; SF<12 microgram/l.

Secondary outcomes

  1. Serum Transferrin Receptor

    Time frame: 6 months, measurements will be done at start and at the end of the intervention

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Nestlé Foundation
  • Noguchi Memorial Institute for Medical Research

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 23, 2010
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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