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Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by The Hospital for Sick Children.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01001871
First received: October 21, 2009
Last updated: October 26, 2009
Last verified: October 2009
  Purpose

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 Intervention
Anemia
Dietary Supplement: Sprinkles®
Dietary Supplement: vitamin/mineral fortificant without iron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) [ Time Frame: 5 months ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 3880
Study Start Date: November 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001871

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

Locations
Ghana
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
Investigators
Principal Investigator: Stanley H Zlotkin, PhD The Hospital for Sick Children, Toronto, Canada
  More Information

No publications provided by The Hospital for Sick Children

Additional 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
Study First Received: October 21, 2009
Last Updated: October 26, 2009
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on November 27, 2014