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
  Purpose

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.


Condition Intervention
Anemia
Undernutrition
Dietary Supplement: micronutrient supplementation

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

Resource links provided by NLM:


Further study details as provided by Centre National de la Recherche Scientifique et Technologique:

Primary Outcome Measures:
  • Anemia [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Growth [ Time Frame: 6 months ]

Enrollment: 297
Study Start Date: August 2006
Study Completion Date: February 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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.
Experimental: 2 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.
Experimental: 3 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.

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

Ages Eligible for Study:   6 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628459

Locations
Burkina Faso
District Sanitaire de Kongoussi
Kongoussi, Burkina Faso
Sponsors and Collaborators
Centre National de la Recherche Scientifique et Technologique
Universite Libre de Bruxelles, Belgium
Fonds pour la recherche scientifique médicale (FRSM), Belgium
Investigators
Study Director: Philippe Donnen, PhD Université Libre de Bruxelles, Belgium
  More Information

Publications:
Responsible Party: Hermann Ouédraogo, chargé de recherche, Institute of Research in Health Sciences
ClinicalTrials.gov Identifier: NCT00628459     History of Changes
Other Study ID Numbers: MIENKO2
Study First Received: February 25, 2008
Last Updated: March 4, 2008
Health Authority: Burkina Faso: Ministry of Health
United States: Federal Government

Keywords provided by Centre National de la Recherche Scientifique et Technologique:
iron
multiple micronutrient
malaria
anemia
preschool children

Additional relevant MeSH terms:
Anemia
Malnutrition
Hematologic Diseases
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014