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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208363
• Other study ID #: COWPEA
• Secondary ID: WUR10/13
• Status: Completed
• Phase: N/A
• First received: September 22, 2010
• Last updated: September 28, 2011
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Low Iron Stores

Intervention

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.

Locations

Country	Name	City	State
Ghana	Department of Community Nutrition, University for Development Studies	Tamale

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Nestlé Foundation, Noguchi Memorial Institute for Medical Research, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron deficiency anemia, defined by Hb<115 g/l; SF<12 microgram/l	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.	Duration will be 6 months. Measurements will be performed at start and after 6 months of intervention.	No
Secondary	Serum Transferrin Receptor		6 months, measurements will be done at start and at the end of the intervention	No