Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana

April 14, 2021 updated by: Stanley Zlotkin, The Hospital for Sick Children

Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

3880

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Kintampo, Ghana, PO Box 200
        • Kintampo Health Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count)
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in anemia status (blood levels of: haemoglobin(Hb) , ferritin (SF))
Time Frame: 5 months
5 months
severity of clinical malaria (blood parasite count)
Time Frame: 5 months
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
5 months
hospitalization (documentation of hospitalization for any reason)
Time Frame: 5 months
5 months
death
Time Frame: 5 months
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
5 months
diarrhea (defined by >3 loose or watery stools in the previous 24 hours)
Time Frame: 5 months
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
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Stanley H Zlotkin, PhD, The Hospital for Sick Children, Toronto, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000013476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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