Nutrition, Diabetes and Pulmonary TB/HIV
The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB: Two Randomized Nutritional Supplementation Trials in Tanzania
1 other identifier
interventional
1,250
1 country
1
Brief Summary
We propose a randomised trial among pulmonary TB patients, examined and treated as part of the national TB control programme (WHO, 2003). The aim is to improve TB treatment outcome in high TB and HIV burden countries. The overall objective of the proposed trial is to assess the effect of nutritional support on TB treatment outcomes, and to assess the role of diabetes on risk and severity of TB, and TB treatment outcomes. The study will be conducted in Mwanza Tanzania. All patients will initially be examined for HIV and diabetes. A total of 500 found pulmonary TB smear-positive (PTB+) and HIV positive (HIV+) will be randomised to a daily supplement of 1 versus 6 energy-protein bars throughout treatment, both with full multi-micronutrient (MN) content. A total of 1500 found pulmonary TB smear-negative (PTB-, irrespective of HIV status) and PTB+ and HIV negative (HIV-) will be randomised to 1 daily energy-protein bar containing either low or high MN content.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 3, 2006
CompletedFirst Posted
Study publicly available on registry
April 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedAugust 4, 2009
August 1, 2009
2.9 years
April 3, 2006
August 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight gain
2 and 5 months
Secondary Outcomes (7)
Grip strength
2 and 5 months
Arm muscle and arm fat areas
2 and 5 months
Physical activity
2 and 5 months
HIV load
2 months
CD4 count
2 and 5 months
- +2 more secondary outcomes
Study Arms (4)
No micronutrients
PLACEBO COMPARATORBiscuit without additional micronutrients
Micronutrients
EXPERIMENTALBiscuit with additional micronutrients
1 biscuit
ACTIVE COMPARATOR1 biscuit with micronutrients
6 biscuits
EXPERIMENTAL1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients
Interventions
Randomised, double-blind trial among pulmonary TB patients, except those who are found to be sputum positive and HIV positive. Both arms received a daily biscuit weighing 30 g (4.5 g protein, 615 kJ). The biscuit given to the No micronutrient-arm contained no additional micronutrients. The biscuit given to the Micronutrient-arm contained the following micronutrients: vitamin A 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, vitamin B12 50 microg, folic acid 0.8 mg, niacin 40 mg, vitamin C 200 mg, vitamin E 60 mg, vitamin D3 5 µg / 200 IU, selenium 0.2 mg, copper 5 mg, and zinc 30 mg. The intervention was given for 60 days during initial TB treatment.
Randomised, single-blind trial among sputum-positive HIV-coinfected pulmonary TB patients. Both arms received a daily for biscuit weighing 30 g (4.5 g protein, 615 kJ), with micronutrients (vitamin A 5000 IU, vitamin B1 20 mg, vitamin B2 20 mg, vitamin B6 25 mg, vitamin B12 50 microg, folic acid 0.8 mg, niacin 40 mg, vitamin C 200 mg, vitamin E 60 mg, vitamin D3 5 µg / 200 IU, selenium 0.2 mg, copper 5 mg, and zinc 30 mg). The experimental arm received an additional 5 biscuits without additional micronutrients. Thus, both arms received the same amount of micronutrients. However, the intervention arm received 3690 kJ and 27 g protein per day, while the control arm received 615 kJ and 4.5 g protein. The intervention was given for 60 days during initial TB treatment.
Eligibility Criteria
You may qualify if:
- New sputum smear positive or negative pulmonary TB patients
You may not qualify if:
- pregnant, terminally ill, other serious diseases (except HIV and diabetes), non-residents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- National Institute for Medical Research, Tanzaniacollaborator
- The Danish Medical Research Councilcollaborator
- Danish Council for Development Researchcollaborator
Study Sites (1)
Mwanza Medical Centre, NIMR
Mwanza, Mwanza Region, Tanzania
Related Publications (2)
Range N, Changalucha J, Krarup H, Magnussen P, Andersen AB, Friis H. The effect of multi-vitamin/mineral supplementation on mortality during treatment of pulmonary tuberculosis: a randomised two-by-two factorial trial in Mwanza, Tanzania. Br J Nutr. 2006 Apr;95(4):762-70. doi: 10.1079/bjn20051684.
PMID: 16571156BACKGROUNDAndersen AB, Range NS, Changalucha J, Praygod G, Kidola J, Faurholt-Jepsen D, Krarup H, Grewal HM, Friis H. CD4 lymphocyte dynamics in Tanzanian pulmonary tuberculosis patients with and without HIV co-infection. BMC Infect Dis. 2012 Mar 21;12:66. doi: 10.1186/1471-2334-12-66.
PMID: 22436147DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nyagosya Range, MSc, PhD
Muhimbili Medical Centre, NIMR
- PRINCIPAL INVESTIGATOR
Henrik Friis, MD, PhD
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 3, 2006
First Posted
April 5, 2006
Study Start
April 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 4, 2009
Record last verified: 2009-08