Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

January 25, 2017 updated by: Brian Greenwood, London School of Hygiene and Tropical Medicine

Evaluation of the Safety and Effectiveness of EPI-linked Malaria Intermittent Chemotherapy and Iron Supplementation

Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron supplementation delivered through Expanded Programme on Immunisation vaccination clinics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anaemia is one of the main disease burdens of children in developing countries. Severe anaemia is often fatal, while moderate anaemia leads to growth and cognitive disorders. The incidence of anaemia in children is extremely high in malaria endemic areas since episodes of clinical malaria and asymptomatic parasitaemia result in red cell destruction. It has been shown in Tanzania that the incidence of severe anaemia in infants can be reduced by 30% by regular administration of iron supplements, and by 60% if regular malaria chemoprophylaxis is given in addition. One way to operationalise this research finding, with minimal additional cost to governments and communities, is to link the distribution of iron and antimalarial drugs to the EPI programme. We propose a community-randomised trial to study the effectiveness of intermittent iron supplements and malaria chemotherapy in reducing the incidence of anaemia and clinical malaria, and to investigate any possible interactions of iron and antimalarial drugs with EPI vaccines. The study will have two arms: children in both arms will receive monthly supplies of twice weekly iron supplements when they attend EPI and growth monitoring clinics. In addition, children in arm 1 will receive a placebo when they receive Polio/DPT 2, Polio/DPT 3 and measles vaccines, while those in arm 2 will receive sulfadoxine-pyrimethamine (SP). The baseline incidence of anaemia and malaria, and immune response to EPI vaccines, will be estimated in a sample of children from a non-intervention area adjacent to the study area. The immune response to EPI vaccines, drug side-effects, and the incidence of anaemia and malaria will be compared between the two arms of the study and with the non-intervention area. Any possible 'rebound' in malaria incidence due to impairment of immunity will be monitored and treated during the six months after stopping the chemotherapy and supplementation.

Study Type

Interventional

Enrollment (Actual)

2485

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
    • Upper East Region
      • Navrongo, Upper East Region, Ghana
        • Navrongo 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

2 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All infants living in study clusters without a history of allergy to sulfadoxine-pyrimethamine were eligible for enrollment in the study.

Exclusion Criteria:

  • History of allergy to sulfadoxine-pyrimethamine.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1 Placebo
Drug: Placebo
Active Comparator: 2 Sulfadoxine-pyrimethamine (SP)
Drug: Sulfadoxine-pyrimethamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
incidence of anaemia

Secondary Outcome Measures

Outcome Measure
incidence of clinical malaria
incidence of severe disease and mortality
prevalence of anaemia and parasitaemia
incidence of adverse events

Collaborators and Investigators

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

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Department for International Development, United Kingdom
Kintampo Health Research Centre, Ghana
INDEPTH Network
Navrongo Health Research Centre, Navrongo, Ghana.

Investigators

  • Principal Investigator: Daniel Chandramohan, MD; PhD, London School of Hygiene and Tropical Medicine

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

September 1, 2000

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFID-R7602

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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