Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area

This study has been completed.
Sponsor:
Collaborators:
Universite Libre de Bruxelles, Belgium
Fonds pour la recherche scientifique médicale (FRSM), Belgium
Information provided by:
Centre National de la Recherche Scientifique et Technologique
ClinicalTrials.gov Identifier:
NCT00628459
First received: February 25, 2008
Last updated: March 4, 2008
Last verified: February 2008

February 25, 2008
March 4, 2008
August 2006
February 2007   (final data collection date for primary outcome measure)
Anemia [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00628459 on ClinicalTrials.gov Archive Site
Growth [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Anemia
  • Undernutrition
Dietary Supplement: micronutrient supplementation
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.
  • Active Comparator: 1
    Intervention: Dietary Supplement: micronutrient supplementation
  • Experimental: 2
    Intervention: Dietary Supplement: micronutrient supplementation
  • Experimental: 3
    Intervention: Dietary Supplement: micronutrient supplementation
Smuts CM, Dhansay MA, Faber M, van Stuijvenberg ME, Swanevelder S, Gross R, Benadé AJ. Efficacy of multiple micronutrient supplementation for improving anemia, micronutrient status, and growth in South African infants. J Nutr. 2005 Mar;135(3):653S-659S.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
297
February 2008
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age of 6-23 months
  • hemoglobin concentration range of 70-109 g/L

Exclusion Criteria:

  • severe wasting (weight-for-height z-score < -3)
Both
6 Months to 23 Months
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
 
NCT00628459
MIENKO2
No
Hermann Ouédraogo, chargé de recherche, Institute of Research in Health Sciences
Centre National de la Recherche Scientifique et Technologique
  • Universite Libre de Bruxelles, Belgium
  • Fonds pour la recherche scientifique médicale (FRSM), Belgium
Study Director: Philippe Donnen, PhD Université Libre de Bruxelles, Belgium
Centre National de la Recherche Scientifique et Technologique
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP