Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

NCT ID: NCT00857077

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2485 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2004-06-30

Brief Summary

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

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.

Conditions

Anaemia; Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1 Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 Sulfadoxine-pyrimethamine (SP)

Group Type: ACTIVE_COMPARATOR

Sulfadoxine-pyrimethamine

Intervention Type: DRUG

Interventions

Sulfadoxine-pyrimethamine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Navrongo Health Research Centre, Navrongo, Ghana.

UNKNOWN

Sponsor Role: collaborator

Kintampo Health Research Centre, Ghana

OTHER

Sponsor Role: collaborator

INDEPTH Network

OTHER

Sponsor Role: collaborator

Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Brian Greenwood

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Chandramohan, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Brian Greenwood, MD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Navrongo Health Research Centre

Navrongo, Upper East Region, Ghana

Countries

Ghana

References

Chandramohan D, Owusu-Agyei S, Carneiro I, Awine T, Amponsa-Achiano K, Mensah N, Jaffar S, Baiden R, Hodgson A, Binka F, Greenwood B. Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana. BMJ. 2005 Oct 1;331(7519):727-33. doi: 10.1136/bmj.331.7519.727.

Reference Type: RESULT

PMID: 16195288 (View on PubMed)

Other Identifiers

DFID-R7602

Identifier Type: -

Identifier Source: org_study_id