Improving tuberculosis treatment by high-energy biscuits in Mwanza, Tanzania
| ISRCTN | ISRCTN16552219 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16552219 |
| Protocol serial number | N/A |
| Sponsor | University of Copenhagen (Denmark) |
| Funder | Danish Ministry of Foreign Affairs (Denmark) - Danish International Development Agency (Danida) grant (ref: 09-026RH) |
- Submission date
- 31/08/2010
- Registration date
- 22/09/2010
- Last edited
- 15/05/2014
- 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 Nyagosya Range
Scientific
Scientific
NIMR Muhimbili
PO Box 3436
Dar es Salaam
N/A
Tanzania
| hrange08@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective open labelled randomised controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Improving Efficacy and Safety of TB and HIV Treatment by Nutritional Supplementation in Mwanza, Tanzania: A prospective, randomised, open labelled study |
| Study acronym | TB-PK study |
| Study objectives | A defined, high energy, vitamin and mineral containing nutritional supplement to undernourished tuberculosis (TB) patients during the first two months of intensive treatment will improve drug absorption, ameliorate adverse effects and fasten recovery of lean body mass. |
| Ethics approval(s) | The local medical ethics committee approved on the 1st of June 2010 (ref: NIMR/HQ/R.8a/Vol.IX/953) |
| Health condition(s) or problem(s) studied | Tuberculosis with and without HIV co-infection |
| Intervention | Patients will be randomised to either: 1. Intervention group: Five high energy biscuits containing 1000 kcal plus vitamins, minerals zinc and selenium every day during the intensive phase of the anti TB treatment as part of the Directly Observed Treatment (DOT) regimen. 2. Control group: Standard care |
| Intervention type | Other |
| Primary outcome measure(s) |
Increase in TB drug exposure (AUC) during the first two months in the group receiving intervention compared to the group receiving standard care. |
| Key secondary outcome measure(s) |
1. Improved immune recovery (CD4 increase) and decline in HIV RNA load in the intervention group |
| Completion date | 31/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Sputum smear positive TB patients 2. > 15 years old |
| Key exclusion criteria | 1. Pregnant women 2. Age < 15 years 3. Non-residency of study area 4. Terminal illness (unlikely to survive > 48 hours) 5. Receiving antiretroviral therapy 6. Not willing to participate |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 31/08/2011 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
NIMR Muhimbili
Dar es Salaam
N/A
Tanzania
N/A
Tanzania
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 | 01/06/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
