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Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

NCT01001871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3880

Last updated 2021-04-19

No results posted yet for this study

Summary

Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.

The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.

The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.

Conditions

Interventions

DIETARY_SUPPLEMENT

Sprinkles®

powdered vitamin/mineral fortificant WITH iron sprinkled onto food once a day for 5 months

DIETARY_SUPPLEMENT

vitamin/mineral fortificant without iron

powdered vitamin/mineral fortificant WITHOUT iron sprinkled onto food once a day for 5 months

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Stanley H Zlotkin, PhD · The Hospital for Sick Children, Toronto, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-10-31
Completion
2011-05-31

Countries

  • Ghana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001871 on ClinicalTrials.gov