Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
Primary Purpose
Anemia, Undernutrition
Status
Completed
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
micronutrient supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring iron, multiple micronutrient, malaria, anemia, preschool children
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)
Sites / Locations
- District Sanitaire de Kongoussi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Anemia
Secondary Outcome Measures
Growth
Full Information
NCT ID
NCT00628459
First Posted
February 25, 2008
Last Updated
March 4, 2008
Sponsor
Centre National de la Recherche Scientifique et Technologique
Collaborators
Universite Libre de Bruxelles, Belgium, Fonds pour la recherche scientifique médicale (FRSM), Belgium
1. Study Identification
Unique Protocol Identification Number
NCT00628459
Brief Title
Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre National de la Recherche Scientifique et Technologique
Collaborators
Universite Libre de Bruxelles, Belgium, Fonds pour la recherche scientifique médicale (FRSM), Belgium
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Undernutrition
Keywords
iron, multiple micronutrient, malaria, anemia, preschool children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
297 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
micronutrient supplementation
Intervention 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.
Primary Outcome Measure Information:
Title
Anemia
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Growth
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Donnen, PhD
Organizational Affiliation
Université Libre de Bruxelles, Belgium
Official's Role
Study Director
Facility Information:
Facility Name
District Sanitaire de Kongoussi
City
Kongoussi
Country
Burkina Faso
12. IPD Sharing Statement
Citations:
PubMed Identifier
15735110
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.
Results Reference
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Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
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