Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

NCT01001871 | Completed DMC

• 1 other identifier: 1000013476
• Study Type: interventional
• Target: 3,880
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

Iron deficiency anemia; Sprinkles®; micronutrients; malaria incidence; iron supplement

Outcome Measures

Primary Outcomes (1)

• incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count)

  5 months

Secondary Outcomes (8)

• changes in anemia status (blood levels of: haemoglobin(Hb) , ferritin (SF))

  5 months

• severity of clinical malaria (blood parasite count)

  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)

  5 months

• hospitalization (documentation of hospitalization for any reason)

  5 months

• death

  5 months

Study Arms (2)

Vitamin/mineral fortificant with iron

EXPERIMENTAL

Dietary Supplement: Sprinkles®

Vitamin/mineral fortificant without iron

PLACEBO COMPARATOR

Dietary Supplement: vitamin/mineral fortificant without iron

Interventions

Sprinkles® DIETARY_SUPPLEMENT

powdered vitamin/mineral fortificant WITH iron sprinkled onto food once a day for 5 months

Vitamin/mineral fortificant with iron

vitamin/mineral fortificant without iron DIETARY_SUPPLEMENT

powdered vitamin/mineral fortificant WITHOUT iron sprinkled onto food once a day for 5 months

Vitamin/mineral fortificant without iron

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Kintampo Health Research Centre

Kintampo, PO Box 200, Ghana

Location

Related Publications (5)

• Tchum SK, Sakyi SA, Arthur F, Adu B, Abubakar LA, Oppong FB, Dzabeng F, Amoani B, Gyan T, Asante KP. Effect of iron fortification on anaemia and risk of malaria among Ghanaian pre-school children with haemoglobinopathies and different ABO blood groups. BMC Nutr. 2023 Mar 23;9(1):56. doi: 10.1186/s40795-023-00709-w.

  PMID: 36959634 DERIVED

• Tchum SK, Sakyi SA, Adu B, Arthur F, Oppong FB, Dzabeng F, Amoani B, Gyan T, Poku-Asante K. Impact of IgG response to malaria-specific antigens and immunity against malaria in pre-school children in Ghana. A cluster randomized, placebo-controlled trial. PLoS One. 2021 Jul 20;16(7):e0253544. doi: 10.1371/journal.pone.0253544. eCollection 2021.

  PMID: 34283841 DERIVED

• 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.

  PMID: 28592572 DERIVED

• 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.

  PMID: 27391972 DERIVED

• 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.

  PMID: 24002280 DERIVED

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Interventions

Vitamins; Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Stanley H Zlotkin, PhD

  The Hospital for Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Global Child Health

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 27, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: May 1, 2011
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

GH (1)