Clinical trial NCT00628459: Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Undernutrition
Keywords: iron
multiple micronutrient
malaria
anemia
preschool children
Lead sponsor: Centre National de la Recherche Scientifique et Technologique
Sponsor class: OTHER_GOV
Collaborators: name: Universite Libre de Bruxelles, Belgium
name: Fonds pour la recherche scientifique médicale (FRSM), Belgium
First posted: 2008-03-05
Enrollment: 297
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Anemia
timeFrame: 6 months
Secondary outcomes:
measure: Growth
timeFrame: 6 months
Other outcomes:
Locations:
city: Kongoussi
country: Burkina Faso
facility: District Sanitaire de Kongoussi
Study officials:
affiliation: Université Libre de Bruxelles, Belgium
name: Philippe Donnen, PhD
role: STUDY_DIRECTOR
References:
citation: Smuts CM, Dhansay MA, Faber M, van Stuijvenberg ME, Swanevelder S, Gross R, Benade 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. doi: 10.1093/jn/135.3.653S.