Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

Tracking Information
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; (submitted: October 26, 2009)	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; (submitted: October 26, 2009)	changes in anemia status (blood levels of: haemoglobin(Hb) , ferritin (SF)) [ Time Frame: 5 months ]; severity of clinical malaria (blood parasite count) [ Time Frame: 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) [ Time Frame: 5 months ]; hospitalization (documentation of hospitalization for any reason) [ Time Frame: 5 months ]; death [ Time Frame: 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) [ Time Frame: 5 months ]; diarrhea (defined by >3 loose or watery stools in the previous 24 hours) [ Time Frame: 5 months ]; dehydration (defined by lethargy, sunken eyes, and decreased skin turgor [>2 seconds for skin to return following a skin pinch]) [ Time Frame: 5 months ]
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.
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: 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).
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
Condition ICMJE	Anemia
Intervention ICMJE	Dietary Supplement: Sprinkles® powdered vitamin/mineral fortificant WITH iron sprinkled onto food once a day for 5 months; Dietary Supplement: vitamin/mineral fortificant without iron powdered vitamin/mineral fortificant WITHOUT iron sprinkled onto food once a day for 5 months
Study Arms	Experimental: Vitamin/mineral fortificant with iron Intervention: Dietary Supplement: Sprinkles®; Placebo Comparator: Vitamin/mineral fortificant without iron Intervention: Dietary Supplement: vitamin/mineral fortificant without iron
Publications *	Aimone AM, Brown P, Owusu-Agyei S, Zlotkin SH, Cole DC. Impact of iron fortification on the geospatial patterns of malaria and non-malaria infection risk among young children: a secondary spatial analysis of clinical trial data from Ghana. BMJ Open. 2017 Jun 6;7(5):e013192. doi: 10.1136/bmjopen-2016-013192.; Aimone AM, Brown PE, Zlotkin SH, Cole DC, Owusu-Agyei S. Geo-spatial factors associated with infection risk among young children in rural Ghana: a secondary spatial analysis. Malar J. 2016 Jul 8;15:349. doi: 10.1186/s12936-016-1388-1.; Zlotkin S, Newton S, Aimone AM, Azindow I, Amenga-Etego S, Tchum K, Mahama E, Thorpe KE, Owusu-Agyei S. Effect of iron fortification on malaria incidence in infants and young children in Ghana: a randomized trial. JAMA. 2013 Sep 4;310(9):938-47. doi: 10.1001/jama.2013.277129.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: October 26, 2009)	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: 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
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Stanley H Zlotkin, PhD The Hospital for Sick Children, Toronto, Canada
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