Condition category
Infections and Infestations
Date applied
30/04/2007
Date assigned
30/08/2007
Last edited
30/08/2007
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 Frank Wieringa

ORCID ID

Contact details

Dept. of Internal Medicine
Hasan Sadikin Hospital
Jl. Pasir Kaliki 191
Bandung
40161
Indonesia
+62 22 2038 986
wieringa@tiscali.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WV93-411

Study information

Scientific title

Acronym

TBGIZI ("GIZI" means "nutrition" in Indonesian)

Study hypothesis

Th hypothesis is that supplementation of TB patients with macro- and micronutrients patients during the first 2 months of treatment increases body weight gain, as compared to TB patients on standard TB treatment. Secondary hypothses include that above supplementation will increase the production of pro-inflammatory cytokines as measured by ex-vivo whole blood stimulation assay and that lean body mass increases more in patients receiving micro- and macronutrient supplementation.

Ethics approval

1. The Ethical Review Board of Hasan Sadikin University, University of Padjajaran, Bandung, Indonesia, approved in August 2006
2. The Ethical Advisory Board, Radboud University Nijmegen, The Netherlands, approved on 16 Feb 2007

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Tuberculosis / nutritional status and wasting / nutrition and public health

Intervention

Newly diagnosed TB patients who fullfil the eligiblity criteria will be randomly allocated according to a previously made random list (randomization in blocks of 4) to either standard treatment + nutritional supplementation (75 patients) or standard treatment only (75 patients). Patients allocated to the nutritional supplementation group will receive 3 biscuits per day for 2 months, containg macro- and micronutriets in addition to their standard TB treatment. These 3 biscuits will provide approximately 450 KCal of energy (or approximately 20% of the daily energy requirements), as well as a wide range of minerals and vitamins, in a doses of approximately half the Daily Required Intakes (DRI’s), and NOT containing iron. Patients will be followed up according to standard clinical practice by the health services until the end of the intensive TB drug treatment phase (2 months).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Body weight gain and body composition between start of TB treatment and end of the active phase of treatment (2 months later)

Secondary outcome measures

The following will be assessed at baseline and 2 months:
1. Micronutrient status
2. Production of inflammatory cytokines

Overall trial start date

15/05/2007

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
1. Patients with Ziehl-Neelsen (ZN) staining - positive pulmonary TB
2. Patients starting, or started <2 weeks ago, with the intensive phase of TB treatment
3. Subject is >18 years of age
4. Willing to participate in the study, and signing the informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

No informed consent.

Recruitment start date

15/05/2007

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Indonesia

Trial participating centre

Dept. of Internal Medicine
Bandung
40161
Indonesia

Sponsor information

Organisation

NWO/WOTRO - Netherlands Organisation for Scientific Research (The Netherlands)

Sponsor details

Anna van Saksenlaan 51
The Hague
2593 HW
Netherlands
+31 (0)70 3440763
WOTRO@nwo.nl

Sponsor type

Government

Website

http://www.nwo.nl/nwohome.nsf/pages/NWOA_6UB9S8

Funders

Funder type

Government

Funder name

NWO/WOTRO - Netherlands Organisation for Scientific Research (The Netherlands)

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

Publication citations

Additional files

Editorial Notes