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

ISRCTN	ISRCTN85411059
DOI	https://doi.org/10.1186/ISRCTN85411059
Protocol serial number	LMC-18
Sponsor	University of Oxford (UK)
Funder	The Wellcome Trust (UK) (grant ref: 066828)

Submission date: 21/01/2008
Registration date: 23/01/2008
Last edited: 17/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Newton
Scientific

Microbiology Laboratory
Mahosot Hospital
Vientiane
100
Lao People's Democratic Republic

Email	paul@tropmedres.ac

Study information

Primary study design	Interventional
Study design	An exploratory, double-blind, parallel group, placebo-controlled trial, randomised (variable blocks), superiority trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Thiamin treatment and Plasmodium falciparum malaria in Laos
Study acronym	TIP
Study objectives	The frequency of adverse events after antimalarial therapy will be significantly lower in those who receive thiamin supplementation in comparison to those who do not.
Ethics approval(s)	Ethics approval received from: 1. Oxford Tropical Research Ethics Committee (UK) on the 21st August 2007 (ref: OXTREC 026-07) 2. Lao PDR National Ethics Committee for Health Research (NECHR) on the 18th July 2007
Health condition(s) or problem(s) studied	Malaria, beriberi
Intervention	Treatment arm: Oral thiamin (5 mg tablet) two tablets immediately after antimalarial drugs, followed by two tablets daily for 7 days followed by one tablet daily until day 42. Placebo arm: Physically identical placebo containing no thiamin.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Thiamin
Primary outcome measure(s)	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. 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.
Key secondary outcome measure(s)	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. The secondary outcome measures will be assessed by red cell transketolase assays of washed red cell samples on day 0 and 42.
Completion date	01/12/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	814
Key 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
Key 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).
Date of first enrolment	01/06/2008
Date of final enrolment	01/12/2011

Locations

Countries of recruitment

Lao People's Democratic Republic

Study participating centre

Microbiology Laboratory

Vientiane
100
Lao People's Democratic Republic

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/06/2012		Yes	No
Results article	results	15/07/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes