Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

Study Overview
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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.

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).

Official Title
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Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children

Conditions
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Anemia

Intervention / Treatment
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* Dietary Supplement: Sprinkles®
* Dietary Supplement: vitamin/mineral fortificant without iron


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin/mineral fortificant with iron<br> | Dietary Supplement: Sprinkles®<br>* powdered vitamin/mineral fortificant WITH iron sprinkled onto food once a day for 5 months<br>|
| Placebo Comparator: Vitamin/mineral fortificant without iron<br> | Dietary Supplement: vitamin/mineral fortificant without iron<br>* powdered vitamin/mineral fortificant WITHOUT iron sprinkled onto food once a day for 5 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in anemia status (blood levels of: haemoglobin(Hb) , ferritin (SF)) |  | 5 months | 
| severity of clinical malaria (blood parasite count) |  | 5 months | 
| cerebral malaria (defined by a parasite count >5000/μL blood and a concurrent score of <2 on the Blantyre coma scale, with or without convulsions) |  | 5 months | 
| hospitalization (documentation of hospitalization for any reason) |  | 5 months | 
| death |  | 5 months | 
| pneumonia (defined by the presence of a cough or breathing difficulties, tachypnea, lower chest wall indrawing, and the appearance of consolidation or pleural effusion on a chest X-ray) |  | 5 months | 
| diarrhea (defined by >3 loose or watery stools in the previous 24 hours) |  | 5 months | 
| dehydration (defined by lethargy, sunken eyes, and decreased skin turgor [>2 seconds for skin to return following a skin pinch]) |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron deficiency anemia, Sprinkles®, micronutrients, malaria incidence, iron supplement