A randomised placebo controlled double blind clinical trial of vitamin D in the treatment of tuberculosis
| ISRCTN | ISRCTN35212132 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35212132 |
| Protocol serial number | N/A |
| Sponsor | Bandim Health Project (Guinea-Bissau) |
| Funders | Danish Research Council for Development Research (Denmark) (ref: 91163) - project expenses, University of Aarhus (Denmark) - salary of lead principal investigator, Crinex Pharmaceuticals (France) - free cholecalciferol and placebo |
- Submission date
- 13/04/2004
- Registration date
- 21/05/2004
- Last edited
- 11/02/2009
- 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 Christian Wejse
Scientific
Scientific
Bandim Health Project
Apartado 861
Bissau Codex
1004
Guinea-Bissau
| Phone | +245 255543 |
|---|---|
| wejse@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | TBD |
| Study objectives | Vitamin D plays an important role in the immune system, and may help the host in combatting active infection with Mycobacterium Tuberculosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Tuberculosis |
| Intervention | 100,000 IU cholecalciferol or placebo in drinkable ampoule at diagnosis, 5 months and 8 months clinical follow up (i.e. total 300,000 IU). |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Clinical status (time to cure by sputum clearance, weight gain, clinical score) after treatment |
| Key secondary outcome measure(s) |
Mortality |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | Adult patients diagnosed with tuberculosis (smear positive and smear negative) living in the field site study area |
| Key exclusion criteria | None. Withdrawal if signs of hypercalcaemia or allergy to vitamin D. |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Guinea-Bissau
Study participating centre
Bandim Health Project
Bissau Codex
1004
Guinea-Bissau
1004
Guinea-Bissau
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 | 01/05/2009 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
