Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00857077

Collaborator

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

2,485

Enrollment

Location

Arms

Duration (Months)

55.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anaemia Malaria	Drug: Sulfadoxine-pyrimethamine Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2485 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2000

Actual Study Completion Date :

Jun 1, 2004

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: 1 Placebo

Drug: Placebo

Active Comparator: 2 Sulfadoxine-pyrimethamine (SP)

Drug: Sulfadoxine-pyrimethamine

Outcome Measures

Primary Outcome Measures

incidence of anaemia []

Secondary Outcome Measures

incidence of clinical malaria []
incidence of severe disease and mortality []
prevalence of anaemia and parasitaemia []
incidence of adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Navrongo Health Research Centre	Navrongo	Upper East Region	Ghana

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine
Navrongo Health Research Centre, Navrongo, Ghana.
Kintampo Health Research Centre, Ghana
INDEPTH Network
Department for International Development, United Kingdom

Investigators

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