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

Sponsors

Lead Sponsor: Centre National de la Recherche Scientifique et Technologique

Collaborator: Universite Libre de Bruxelles, Belgium
Fonds pour la recherche scientifique médicale (FRSM), Belgium

Source Centre National de la Recherche Scientifique et Technologique
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.

Overall Status Completed
Start Date August 2006
Completion Date February 2008
Primary Completion Date February 2007
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Anemia 6 months
Secondary Outcome
Measure Time Frame
Growth 6 months
Enrollment 297
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: micronutrient supplementation

Description: 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.

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)

Gender: All

Minimum Age: 6 Months

Maximum Age: 23 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Philippe Donnen, PhD Study Director Université Libre de Bruxelles, Belgium
Location
Facility: District Sanitaire de Kongoussi
Location Countries

Burkina Faso

Verification Date

February 2008

Responsible Party

Name Title: Hermann Ouédraogo, chargé de recherche

Organization: Institute of Research in Health Sciences

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: 1

Type: Active Comparator

Label: 2

Type: Experimental

Label: 3

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov