Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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Study Design:

The proposed study is a community-based blinded randomized controlled trial with 2 study arms that will be conducted in two phases:

* Phase I will take place during the dry season (December to April), when malaria transmission rates are lower. Eligible subjects (one per household) will be individually randomized to receive a daily dose of either a powdered vitamin/mineral fortificant containing 12.5 mg of iron (plus ascorbic acid, vitamin A and zinc), or a placebo (containing all micronutrients excluding iron), added to complementary foods, for 5 months.
* Phase II will take place during the wet season (June to October), when malaria transmission rates are higher. Eligible subjects, who did not participate in Phase I, will be individually randomized to one of the two study arms as described above and followed for 5 months.

A dual phase design, with two unique cohorts, was chosen so that preliminary results (at the end of phase 1) could be assessed by an independent Data Safety and Monitoring Committee. It is possible that during the dry season no impact of iron will be detected, while during the wet season, an impact will be observed. With this possible outcome, it is potentially feasible to translate this knowledge into a Ministry of Health Program to only provide iron supplementation (fortification) during the dry months of the year (December to April).

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin/mineral fortificant with iron

Group Type EXPERIMENTAL

Sprinkles®

Intervention Type DIETARY_SUPPLEMENT

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

Vitamin/mineral fortificant without iron

Group Type PLACEBO_COMPARATOR

vitamin/mineral fortificant without iron

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Sprinkles®

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

Intervention Type DIETARY_SUPPLEMENT

vitamin/mineral fortificant without iron

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 6-24 months
* Ingesting weaning food in addition to breastmilk
* Free from malaria or other major illnesses
* Afebrile
* Living in Brong Ahafo Region of Ghana for duration of intervention and follow-up

Exclusion Criteria

* Severe anemia (hemoglobin \<70g/L)
* Weight-for-height \<-3 z-score(severe wasting)
* Kwashiorkor (defined as evidence of edema)
* Congenital abnormality
* Treatment with iron supplements within the past 6 months
* Presence of any chronic illness

Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes