Clinical trial NCT01208363: Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study
Official title: Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Low Iron Stores
Keywords: Iron fortification
polyphenols
NaFeEDTA
cowpea
school feeding program
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Noguchi Memorial Institute for Medical Research
name: Nestlé Foundation
First posted: 2010-09-23
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Iron deficiency anemia, defined by Hb<115 g/l; SF<12 microgram/l
timeFrame: Duration will be 6 months. Measurements will be performed at start and after 6 months of intervention.
Secondary outcomes:
measure: Serum Transferrin Receptor
timeFrame: 6 months, measurements will be done at start and at the end of the intervention
Other outcomes:
Locations:
city: Tamale
country: Ghana
facility: Department of Community Nutrition, University for Development Studies
Study officials:
affiliation: Division of Human Nutrition, Wageningen University
name: Abdul R Abizari, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abizari AR, Moretti D, Zimmermann MB, Armar-Klemesu M, Brouwer ID. Whole cowpea meal fortified with NaFeEDTA reduces iron deficiency among Ghanaian school children in a malaria endemic area. J Nutr. 2012 Oct;142(10):1836-42. doi: 10.3945/jn.112.165753. Epub 2012 Aug 22.