Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311298
Status:
COMPLETED
Last Update Posted:
2009-08-04
First Post:
2006-04-03
Brief Title:
Nutrition Diabetes and Pulmonary TBHIV
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB Two Randomized Nutritional Supplementation Trials in Tanzania
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None