NCT00628459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

March 5, 2008

Status Verified

February 1, 2008

Enrollment Period

6 months

First QC Date

February 25, 2008

Last Update Submit

March 4, 2008

Conditions

AnemiaUndernutrition

Keywords

ironmultiple micronutrientmalariaanemiapreschool children

Outcome Measures

Primary Outcomes (1)

  • Anemia

    6 months

Secondary Outcomes (1)

  • Growth

    6 months

Study Arms (3)

1

ACTIVE COMPARATOR
Dietary Supplement: micronutrient supplementation

2

EXPERIMENTAL
Dietary Supplement: micronutrient supplementation

3

EXPERIMENTAL
Dietary Supplement: micronutrient supplementation

Interventions

micronutrient supplementationDIETARY_SUPPLEMENT

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.

123

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age of 6-23 months
  • hemoglobin concentration range of 70-109 g/L

You may not qualify if:

  • severe wasting (weight-for-height z-score \< -3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Sanitaire de Kongoussi

Kongoussi, Burkina Faso

Location

Related Publications (1)

  • 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.

    PMID: 15735110BACKGROUND

MeSH Terms

Conditions

AnemiaMalnutritionMalaria

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNutrition DisordersNutritional and Metabolic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Philippe Donnen, PhD

    Université Libre de Bruxelles, Belgium

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

August 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2008

Last Updated

March 5, 2008

Record last verified: 2008-02

Locations

BU(1)