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Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00857077
Enrollment
2485
Registered
2009-03-06
Start date
2000-09-30
Completion date
2004-06-30
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia, Malaria

Keywords

incidence of anaemia

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.

Interventions

DRUGSulfadoxine-pyrimethamine
DRUGPlacebo

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Months to 24 Months
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.

Design outcomes

Primary

MeasureTime frame
incidence of anaemia

Secondary

MeasureTime frame
incidence of clinical malaria
incidence of severe disease and mortality
prevalence of anaemia and parasitaemia
incidence of adverse events

Countries

Ghana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026