Clinical trial NCT00857077: Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana
Official title: Evaluation of the Safety and Effectiveness of EPI-linked Malaria Intermittent Chemotherapy and Iron Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaemia
Malaria
Keywords: incidence of anaemia
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Navrongo Health Research Centre, Navrongo, Ghana.
name: Kintampo Health Research Centre, Ghana
name: INDEPTH Network
name: Department for International Development, United Kingdom
First posted: 2009-03-06
Enrollment: 2485
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: incidence of anaemia
Secondary outcomes:
measure: incidence of clinical malaria
measure: incidence of severe disease and mortality
measure: prevalence of anaemia and parasitaemia
measure: incidence of adverse events
Other outcomes:
Locations:
city: Navrongo
country: Ghana
facility: Navrongo Health Research Centre
state: Upper East Region
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Daniel Chandramohan, MD; PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Brian Greenwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.