Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study
Condition: Anemia; Low Iron Stores
Study type: Interventional

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.
    


Intervention name(s): Cowpea fortified with NaFeEDTA, in form of Toubani.
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Intervention MeSH terms: Fe(III)-EDTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Iron fortification; polyphenols; NaFeEDTA; cowpea; school feeding program