Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2009 by The Hospital for Sick Children.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01001871

First Posted: October 27, 2009

Last Update Posted: October 27, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

The Hospital for Sick Children

Tracking Information

First Submitted Date ^ICMJE

October 21, 2009

First Posted Date ^ICMJE

October 27, 2009

Last Update Posted Date

October 27, 2009

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

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 Provided

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 *

* 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

3880

Estimated 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

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