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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
Information provided by:
The Hospital for Sick 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.

Condition or disease Intervention/treatment
Anemia Dietary Supplement: Sprinkles® Dietary Supplement: vitamin/mineral fortificant without iron

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 3880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children
Study Start Date : November 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vitamin/mineral fortificant with iron Dietary Supplement: Sprinkles®
powdered vitamin/mineral fortificant WITH iron sprinkled onto food once a day for 5 months
Placebo Comparator: Vitamin/mineral fortificant without iron Dietary Supplement: vitamin/mineral fortificant without iron
powdered vitamin/mineral fortificant WITHOUT iron sprinkled onto food once a day for 5 months

Primary Outcome Measures :
  1. incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. changes in anemia status (blood levels of: haemoglobin(Hb) , ferritin (SF)) [ Time Frame: 5 months ]
  2. severity of clinical malaria (blood parasite count) [ Time Frame: 5 months ]
  3. 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 ]
  4. hospitalization (documentation of hospitalization for any reason) [ Time Frame: 5 months ]
  5. death [ Time Frame: 5 months ]
  6. 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 ]
  7. diarrhea (defined by >3 loose or watery stools in the previous 24 hours) [ Time Frame: 5 months ]
  8. dehydration (defined by lethargy, sunken eyes, and decreased skin turgor [>2 seconds for skin to return following a skin pinch]) [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001871

Contact: Stanley Zlotkin 416-813-6171 stanley.zlotkin@sickkids.ca

Kintampo Health Research Centre Not yet recruiting
Kintampo, Ghana, PO Box 200
Principal Investigator: Stanley Zlotkin, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Stanley H Zlotkin, PhD The Hospital for Sick Children, Toronto, Canada

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanley Zlotkin/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01001871     History of Changes
Other Study ID Numbers: 1000013476
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by The Hospital for Sick Children:
Iron deficiency anemia
malaria incidence
iron supplement

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Growth Substances
Physiological Effects of Drugs
Trace Elements