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

Summary

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.

Conditions

• Anemia
• Low Iron Stores

Interventions

DIETARY_SUPPLEMENT

Cowpea fortified with NaFeEDTA, in form of Toubani.

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.

Sponsors & Collaborators

• Noguchi Memorial Institute for Medical Research

  collaborator OTHER

• Nestlé Foundation

  collaborator OTHER

• Wageningen University

  lead OTHER

Principal Investigators

• Abdul R Abizari, Msc · Division of Human Nutrition, Wageningen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2011-04-30

Completion

2011-07-31

Countries

• Ghana

Study Locations