Does thiamin treatment reduce the incidence of adverse effects during treatment of falciparum malaria?

Completed

• Conditions: Malaria, beriberi; Infections and Infestations; Malaria

• Registration Number: ISRCTN85411059
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 814

Inclusion Criteria

1. Written fully informed consent given by patients and in the case of children, by parents or guardians
2. Males and females of any age
3. Microscopically confirmed Plasmodium falciparum infection with history of fever. Multiple Plasmodium species infections will be included.
4. Willingness and ability to comply with the study protocol for the duration of the 42 days follow up
5. Did not take a full course of any antimalarial drugs in previous three days

Exclusion Criteria

1. Known hypersensitivity to thiamin
2. Presence of intercurrent non-malarial illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
3. Clinically apparent suspected thiamin deficiency (beriberi), which will be defined (World Health Organization [WHO] 1999) as:
3.1. Children less than 5 years: peripheral oedema or clinical evidence for pulmonary oedema, or cyanosis or classical hoarse cry
3.2. Adults and children greater than 5 years: peripheral oedema or clinical evidence for pulmonary oedema or lower limb paraesthesia or, before malarial illness, difficulty in rising from squatting position (it will be difficult to distinguish features of wet beriberi, such as peripheral and pulmonary oedema, from consequences of malaria, such as severe anaemia, acute respiratory distress syndrome [ARDS] and pneumonia. Clinicians will be cautious and classify the patient as having beriberi if there is doubt).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether the frequency of adverse events, after antimalarial therapy, are significantly lower in those who receive thiamin supplementation in comparison to those who do not.<br><br>For the primary endpoint the outcome measure will be assessed clinically before treatment and on each day until discharge and then on days 7, 14, 21, 28, 38 and 42 after start of treatment.

Secondary Outcome Measures

Name	Time	Method
To determine the frequency of biochemical thiamin deficiency and whether this is related to the clinical severity of disease and the extent of resolution of deficiency between those who do and do not receive thiamin supplementation.<br><br>The secondary outcome measures will be assessed by red cell transketolase assays of washed red cell samples on day 0 and 42.