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

Sponsors and Collaborators:	Centre National de la Recherche Scientifique et Technologique 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

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

MedlinePlus related topics: Anemia Dietary Supplements Malaria

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Iodine Cadexomer iodine Vitamin A Retinol Vitamin D Ergocalciferol Vitamin K Riboflavin Thiamine 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-m- ethylthiazolium chloride, monohydrochloride Ascorbic acid Niacin Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study

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
1: Active Comparator	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.
2: Experimental	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.
3: Experimental	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

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:

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.

Responsible Party:	Institute of Research in Health Sciences ( Hermann Ouédraogo, chargé de recherche )
Study ID Numbers:	MIENKO2
Study First Received:	February 25, 2008
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00628459
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

Study placed in the following topic categories:

Malaria
Copper
Vitamin B 6
Tocopherols
Nicotinic Acids
Malnutrition
Retinol palmitate
Zinc
Iodine
Nutrition Disorders
Tocopherol acetate
Hematologic Diseases
Hydroxocobalamin
Anemia

Ergocalciferols
Thiamine
Vitamin B 12
Alpha-Tocopherol
Folic Acid
Vitamin E
Vitamin D
Riboflavin
Vitamin A
Vitamin K
Pyridoxine
Iron
Niacin
Ascorbic Acid

ClinicalTrials.gov processed this record on January 16, 2009