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

This study has been completed.
Sponsor:
Collaborators:
Noguchi Memorial Institute for Medical Research, University of Ghana
Nestlé Foundation
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01208363
First received: September 22, 2010
Last updated: September 28, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Anemia
Low Iron Stores
Dietary Supplement: Cowpea fortified with NaFeEDTA, in form of Toubani.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Serum Transferrin Receptor [ Time Frame: 6 months, measurements will be done at start and at the end of the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Unfortified Toubani
Children in the school will receive, 3 times per week 66g of raw unfortified (no added Fe) cowpea in form of Toubani (a cowpea based snack).
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.
Active Comparator: Fortified Cowpea
Study subjects will receive 3 times per week, as part of the school feeding programme 66g of raw fortified cowpea (with added 10mg Fe as NaFeEDTA)in form of Toubani (a cowpea based snack).
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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208363

Locations
Ghana
Department of Community Nutrition, University for Development Studies
Tamale, Ghana
Sponsors and Collaborators
Wageningen University
Noguchi Memorial Institute for Medical Research, University of Ghana
Nestlé Foundation
Investigators
Principal Investigator: Abdul R Abizari, Msc Division of Human Nutrition, Wageningen University
  More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01208363     History of Changes
Other Study ID Numbers: COWPEA, WUR10/13
Study First Received: September 22, 2010
Last Updated: September 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wageningen University:
Iron fortification
polyphenols
NaFeEDTA
cowpea
school feeding program

ClinicalTrials.gov processed this record on September 18, 2014