Nutrition, Diabetes and Pulmonary TB/HIV
Primary Purpose
Tuberculosis, HIV, Diabetes
Status
Completed
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
Multimicronutrients
Energy and proteins
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis focused on measuring tuberculosis, hiv, diabetes, protein-energy, micronutrients
Eligibility Criteria
Inclusion Criteria: New sputum smear positive or negative pulmonary TB patients Exclusion Criteria: pregnant, terminally ill, other serious diseases (except HIV and diabetes), non-residents
Sites / Locations
- Mwanza Medical Centre, NIMR
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Active Comparator
Experimental
Arm Label
No micronutrients
Micronutrients
1 biscuit
6 biscuits
Arm Description
Biscuit without additional micronutrients
Biscuit with additional micronutrients
1 biscuit with micronutrients
1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients
Outcomes
Primary Outcome Measures
Weight gain
Secondary Outcome Measures
Grip strength
Arm muscle and arm fat areas
Physical activity
HIV load
CD4 count
Serum acute phase reactants
Mortality
Full Information
NCT ID
NCT00311298
First Posted
April 3, 2006
Last Updated
August 3, 2009
Sponsor
University of Copenhagen
Collaborators
National Institute for Medical Research, Tanzania, The Danish Medical Research Council, Danish Council for Development Research
1. Study Identification
Unique Protocol Identification Number
NCT00311298
Brief Title
Nutrition, Diabetes and Pulmonary TB/HIV
Official Title
The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB: Two Randomized Nutritional Supplementation Trials in Tanzania
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
National Institute for Medical Research, Tanzania, The Danish Medical Research Council, Danish Council for Development Research
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, HIV, Diabetes
Keywords
tuberculosis, hiv, diabetes, protein-energy, micronutrients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No micronutrients
Arm Type
Placebo Comparator
Arm Description
Biscuit without additional micronutrients
Arm Title
Micronutrients
Arm Type
Experimental
Arm Description
Biscuit with additional micronutrients
Arm Title
1 biscuit
Arm Type
Active Comparator
Arm Description
1 biscuit with micronutrients
Arm Title
6 biscuits
Arm Type
Experimental
Arm Description
1 biscuit with micronutrients, plus 5 biscuits without additional micronutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
Multimicronutrients
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Energy and proteins
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
2 and 5 months
Secondary Outcome Measure Information:
Title
Grip strength
Time Frame
2 and 5 months
Title
Arm muscle and arm fat areas
Time Frame
2 and 5 months
Title
Physical activity
Time Frame
2 and 5 months
Title
HIV load
Time Frame
2 months
Title
CD4 count
Time Frame
2 and 5 months
Title
Serum acute phase reactants
Time Frame
2 months
Title
Mortality
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New sputum smear positive or negative pulmonary TB patients
Exclusion Criteria:
pregnant, terminally ill, other serious diseases (except HIV and diabetes), non-residents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nyagosya Range, MSc, PhD
Organizational Affiliation
Muhimbili Medical Centre, NIMR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Friis, MD, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mwanza Medical Centre, NIMR
City
Mwanza
Country
Tanzania
12. IPD Sharing Statement
Citations:
PubMed Identifier
16571156
Citation
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.
Results Reference
background
PubMed Identifier
22436147
Citation
Andersen 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.
Results Reference
derived
Links:
URL
http://www.nimr.or.tz/
Description
National Institute of Medical Research
Learn more about this trial
Nutrition, Diabetes and Pulmonary TB/HIV
We'll reach out to this number within 24 hrs