Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana (NCT01001871) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana
Ghana3,880 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range
6 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count)