Prevention of Severe Anaemia in Gambian Children

NCT00131716 | Completed Phase 3 DMC

• 1 other identifier: ITCRVG33.
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10% of such children die. In endemic countries, anaemia has multiple causes such as nutritional deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is believed to be the major contributory factor to the aetiology of severe anaemia. Severe anaemia is usually treated by blood transfusion although transfusion carries the attendant risk of transmission of HIV and other blood-borne infections. Thus, there is a need to explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such as children with suboptimal haemoglobin levels because these children are at increased risk of developing severe anaemia if they develop a malaria infection before their haemoglobin level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect Gambian children from developing severe anaemia. After receiving treatment from the hospital, 1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to receive either monthly S/P or placebo during the rest of the malaria transmission season. Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of the dry season to document morbidity and mortality.

Conditions

Anemia

Keywords

prevention; recurrence; severe; anaemia

Outcome Measures

Primary Outcomes (3)

• Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl

  at end of the malaria transmission season

• haemoglobin concentration

  At the end of malaria transmission season

• hemoglobin concentration

  at the end of malaria transmission season

Secondary Outcomes (8)

• Proportion of children with anaemia (Hb <11g/dl) and those with severe anaemia (Hb <5 g/dl)

  at end of the malaria transmission season

• Mean Hb : Difference between S/P and placebo, Difference between S/P and placebo adjusted for baseline Hb and other covariates

  at the end of the malaria transmission season

• Number of outpatient department (OPD) attendances with malaria

  during the surveillance period

• Number of hospital admissions with malaria

  during the surveillance period

• Number of episodes of severe malaria

  during the surveillance period

Interventions

sulfadoxine-pyrimethamine DRUG

Eligibility Criteria

• Age: 3 Months - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 3 months to 9 years.
• Haemoglobin concentration 7g/dl on admission to hospital.
• Residence within 30 km of the study centre and availability for the duration of the study period.
• Informed consent to participate in the study given by the parent or guardian.

You may not qualify if:

• Simultaneous participation in any other trial.
• Allergy to sulpha drugs.
• Residence \> 30 km from the recruitment site.
• Lack of consent.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Department of State for Health and Social Welfare, The Gambia: collaborator

Study Sites (1)

Medical Research Council Laboratories,

Banjul, The Gambia

Location

Related Publications (1)

• Bojang KA, Milligan PJ, Conway DJ, Sisay-Joof F, Jallow M, Nwakanma DC, Abubakr I, Njie F, Greenwood B. Prevention of the recurrence of anaemia in Gambian children following discharge from hospital. PLoS One. 2010 Jun 21;5(6):e11227. doi: 10.1371/journal.pone.0011227.

  PMID: 20574541 DERIVED

MeSH Terms

Conditions

Anemia; Recurrence; Lymphoma, Follicular

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Brian Greenwood, MD

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 19, 2005
• Study Start: May 1, 2003
• Study Completion: May 1, 2005
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

TH (1)