Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

This study has been completed.
Sponsor:
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
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00857077
First received: March 5, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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


Condition Intervention
Anaemia
Malaria
Drug: Sulfadoxine-pyrimethamine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Safety and Effectiveness of EPI-Linked Malaria Intermittent Chemotherapy and Iron Supplementation

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • incidence of anaemia [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of clinical malaria [ Designated as safety issue: No ]
  • incidence of severe disease and mortality [ Designated as safety issue: No ]
  • prevalence of anaemia and parasitaemia [ Designated as safety issue: No ]
  • incidence of adverse events [ Designated as safety issue: No ]

Enrollment: 2485
Study Start Date: September 2000
Study Completion Date: June 2004
Arms Assigned Interventions
Placebo Comparator: 1 Placebo Drug: Placebo
Active Comparator: 2 Sulfadoxine-pyrimethamine (SP) Drug: Sulfadoxine-pyrimethamine

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

Ages Eligible for Study:   2 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857077

Locations
Ghana
Navrongo Health Research Centre
Navrongo, Upper East Region, Ghana
Sponsors and Collaborators
Gates Malaria Partnership
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
  More Information

Publications:
Responsible Party: Dr Daniel Chandramohan, London School of Hygiene & Tropical Medicine
ClinicalTrials.gov Identifier: NCT00857077     History of Changes
Other Study ID Numbers: DFID-R7602
Study First Received: March 5, 2009
Last Updated: March 5, 2009
Health Authority: Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:
incidence of anaemia

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Sulfadoxine
Pyrimethamine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014