Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

The Hospital for Sick Children

Status: Completed

Conditions: Anemia

Treatments: Dietary Supplement: vitamin/mineral fortificant without iron; Dietary Supplement: Sprinkles®

Study type: Interventional

Funder types: Other

Identifiers

NCT01001871

1000013476

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 3,880 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,880 participants in 2 patient groups, including a placebo group

Vitamin/mineral fortificant with iron

Experimental group

Treatment:

Dietary Supplement: Sprinkles®

Vitamin/mineral fortificant without iron

Placebo Comparator group

Treatment:

Dietary Supplement: vitamin/mineral fortificant without iron