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

Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628459
• Other study ID #: MIENKO2
• Status: Completed
• Phase: N/A
• First received: February 25, 2008
• Last updated: March 4, 2008
• Start date: August 2006
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Centre National de la Recherche Scientifique et Technologique
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of HealthUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: February 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 23 Months

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Malnutrition
• Undernutrition

Intervention

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.

Locations

Country	Name	City	State
Burkina Faso	District Sanitaire de Kongoussi	Kongoussi

Sponsors (3)

Lead Sponsor	Collaborator
Centre National de la Recherche Scientifique et Technologique	Fonds pour la recherche scientifique médicale (FRSM), Belgium, Universite Libre de Bruxelles, Belgium

Country where clinical trial is conducted

Burkina Faso, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia		6 months
Secondary	Growth		6 months