Does thiamin treatment reduce the incidence of adverse effects during treatment of falciparum malaria?
| ISRCTN | ISRCTN85411059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85411059 |
| Secondary identifying numbers | LMC-18 |
- 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
Scientific
Microbiology Laboratory
Mahosot Hospital
Vientiane
100
Lao People's Democratic Republic
| paul@tropmedres.ac |
Study information
| Study design | An exploratory, double-blind, parallel group, placebo-controlled trial, randomised (variable blocks), superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Thiamin |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/06/2008 |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
100
Lao People's Democratic Republic
Sponsor information
University of Oxford (UK)
University/education
University/education
Churchill Hospital
CCVTM
Headington
Oxford
OX3 7LJ
England
United Kingdom
| research.services@admin.ox.ac.uk | |
| Website | http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 066828)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
