Nutrition and wasting in tuberculosis (TB): Can nutritional supplementation in TB patients improve body weight gain, body composition and treatment outcome?
| ISRCTN | ISRCTN16469166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16469166 |
| Protocol serial number | WV93-411 |
| Sponsor | NWO/WOTRO - Netherlands Organisation for Scientific Research (The Netherlands) |
| Funder | NWO/WOTRO - Netherlands Organisation for Scientific Research (The Netherlands) |
- Submission date
- 30/04/2007
- Registration date
- 30/08/2007
- Last edited
- 30/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Frank Wieringa
Scientific
Scientific
Dept. of Internal Medicine
Hasan Sadikin Hospital
Jl. Pasir Kaliki 191
Bandung
40161
Indonesia
| Phone | +62 22 2038 986 |
|---|---|
| wieringa@tiscali.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | TBGIZI ("GIZI" means "nutrition" in Indonesian) |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 (DRIs), 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 |
| Primary outcome measure(s) |
Body weight gain and body composition between start of TB treatment and end of the active phase of treatment (2 months later) |
| Key secondary outcome measure(s) |
The following will be assessed at baseline and 2 months: |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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 |
| Key exclusion criteria | No informed consent. |
| Date of first enrolment | 15/05/2007 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Dept. of Internal Medicine
Bandung
40161
Indonesia
40161
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
