Improving tuberculosis treatment by high-energy biscuits in Mwanza, Tanzania

ISRCTN	ISRCTN16552219
DOI	https://doi.org/10.1186/ISRCTN16552219
Secondary identifying numbers	N/A

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

Not provided at time of registration

Contact information

Dr Nyagosya Range
Scientific

NIMR Muhimbili
PO Box 3436
Dar es Salaam
N/A
Tanzania

Email	hrange08@gmail.com

Study information

Study design	Prospective open labelled randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Is prepared in English and in local language. Will in addition be orally presented to participants by study nurses.
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 hypothesis	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)
Condition	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	Increase in TB drug exposure (AUC) during the first two months in the group receiving intervention compared to the group receiving standard care.
Secondary outcome measures	1. Improved immune recovery (CD4 increase) and decline in HIV RNA load in the intervention group 2. Improved and faster increase in lean body mass and physical strength 3. Less reporting of adverse effects
Overall study start date	01/09/2010
Overall study end date	31/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Participant inclusion criteria	1. Sputum smear positive TB patients 2. > 15 years old
Participant 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
Recruitment start date	01/09/2010
Recruitment end date	31/08/2011

Locations

Countries of recruitment

Tanzania

Study participating centre

NIMR Muhimbili

Dar es Salaam
N/A
Tanzania

Sponsor information

University of Copenhagen (Denmark)
University/education

c/o Aase Bengaard Andersen
Faculty of health Sciences
Department of Infectious Diseases
Rigshospitalet
Blegdamsvej 9
Copenhagen
2100
Denmark

Email	bengaard@dadlnet.dk
"ROR"	https://ror.org/035b05819

Funders

Funder type

Government

Danish Ministry of Foreign Affairs (Denmark) - Danish International Development Agency (Danida) grant (ref: 09-026RH)

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	01/06/2014		Yes	No