Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
Condition: Anemia; Undernutrition
MeSH terms: Anemia; Malnutrition
Study type: Interventional

Summary: 
      Some micronutrients are likely to interact with malaria parasite, leading to either
      synergistic or antagonist effect on malaria morbidity and therefore on hemoglobin response.

      The purpose of this study is to investigate the effect of supplementation with iron or
      multiple micronutrients on anemia while integrated with malaria management in rural Burkinabe
      young anemic children with high prevalence of malaria.
    

Detailed description: 
      This is a community-based randomised double-blind trial. Children aged 6-23 months are
      randomised to receive either iron (n=91), iron and zinc (IZ, n=90) or MMN (n=89), 5 days/week
      for 6 months. Supplements are manufactured by Nutriset (Malaunay, France) as specifically
      fortified "plumpy-nut". They are presented in 90 ml boxes coded A, B and C each lot of boxes
      contained in white packing labelled A, B and C respectively. Malaria is managed in
      concordance with the national malaria program standards. All mothers receive one
      insecticide-treated bed-net (PermaNet®, Vestergaard Frandsen Disease Control Textiles) and
      instruction for effective utilization for children. All children with positive smear for
      Plasmodium falciparum are artemether+lumefantrine-treated (Coartem®, Novartis Pharma S.A.S.,
      France) regardless of the clinical status. Children aged of at least 12 months receive 200 mg
      albendazole, one week prior to the supplementation starting.

      Data collection involves:

        -  a questionnaire addressed to mothers at baseline,

        -  a medical examination of mothers and children at baseline: A general practitioner
           examines mothers for goiter determination according to the International Council for the
           Control of Iodine Deficiency Disorders (ICCIDD) definition and classification, and
           children for splenomegaly that is classified according to Hackett. Anthropometrical
           measurements are performed on children and mothers by a nutritionist, in agreement with
           the WHO recommendations. Children's capillary blood is obtained by lab technicians
           through a finger stick for hemoglobin measurement and malaria blood smear preparation.
           Hemoglobin is measured using a HemoCue® machine (Hemocue HB 201+, Angelholm, Sweden) to
           the nearest 1g/L.

        -  malaria microscopic detection at baseline and monthly during the study: blood smears
           intending to detect malaria infection are stained with Giemsa, and read in duplicate at
           the local hospital laboratory,

        -  a daily record of supplementation and morbidity data (diarrhoea, fever, cough).

      The endpoints considered for analysis are change of hemoglobin (final haemoglobin minus
      baseline haemoglobin concentration) and final anemia status that are analysed by multiple
      linear regression and logistic regression respectively.
    

Intervention name(s): micronutrient supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Supplements are given daily, 5days/week, for 6 months, involving 15 mg iron (arm 1), 15 mg iron and 10 mg zinc (arm 2), or multiple micronutrient (arm 3): 15 mg iron, 10 mg zinc, 375 µg vitamin A, 5 µg vitamin D, 6 mg vitamin E, 0.5 mg vitamin B1, 0.5 mg vitamin B2, 6 mg niacin, 150 µg folic acid, 0.5 mg vitamin B6, 0.9 mg vitamin B12, 35 mg vitamin C, 10 µg vitamin K, 50 µg iodine, 0.6 mg copper.
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: iron; multiple micronutrient; malaria; anemia; preschool children