Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana
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ClinicalTrials.gov Identifier: NCT01001871 |
Recruitment Status
: Unknown
Verified October 2009 by The Hospital for Sick Children.
Recruitment status was: Not yet recruiting
First Posted
: October 27, 2009
Last Update Posted
: October 27, 2009
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Tracking Information | ||||
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First Submitted Date ICMJE | October 21, 2009 | |||
First Posted Date ICMJE | October 27, 2009 | |||
Last Update Posted Date | October 27, 2009 | |||
Study Start Date ICMJE | November 2009 | |||
Estimated Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) [ Time Frame: 5 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana | |||
Official Title ICMJE | Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children | |||
Brief 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. |
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Detailed 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:
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). |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Anemia | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
3880 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | May 2011 | |||
Estimated Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 6 Months to 24 Months (Child) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Ghana | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01001871 | |||
Other Study ID Numbers ICMJE | 1000013476 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Stanley Zlotkin/Principal Investigator, The Hospital for Sick Children | |||
Study Sponsor ICMJE | The Hospital for Sick Children | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | The Hospital for Sick Children | |||
Verification Date | October 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |