Condition category
Infections and Infestations
Date applied
31/08/2010
Date assigned
22/09/2010
Last edited
15/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nyagosya Range

ORCID ID

Contact details

NIMR Muhimbili
PO Box 3436
Dar es Salaam
N/A
Tanzania
hrange08@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Improving Efficacy and Safety of TB and HIV Treatment by Nutritional Supplementation in Mwanza, Tanzania: A prospective, randomised, open labelled 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

The local medical ethics committee approved on the 1st of June 2010 (ref: NIMR/HQ/R.8a/Vol.IX/953)

Study design

Prospective open labelled randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Is prepared in English and in local language. Will in addition be orally presented to participants by study nurses.

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2010

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sputum smear positive TB patients
2. > 15 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

Trial participating centre

NIMR Muhimbili
Dar es Salaam
N/A
Tanzania

Sponsor information

Organisation

University of Copenhagen (Denmark)

Sponsor details

c/o Aase Bengaard Andersen
Faculty of health Sciences
Department of Infectious Diseases
Rigshospitalet
Blegdamsvej 9
Copenhagen
2100
Denmark
bengaard@dadlnet.dk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24709267

Publication citations

  1. Results

    Jeremiah K, Denti P, Chigutsa E, Faurholt-Jepsen D, PrayGod G, Range N, Castel S, Wiesner L, Hagen CM, Christiansen M, Changalucha J, McIlleron H, Friis H, Andersen AB, Nutritional supplementation increases rifampin exposure among tuberculosis patients coinfected with HIV., Antimicrob. Agents Chemother., 2014, 58, 6, 3468-3474, doi: 10.1128/AAC.02307-13.

Additional files

Editorial Notes