Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis

NCT01635153 | Completed Results DMC

• 2 other identifiers: DarDar 2-C CPHS 21592 D12221RO1 503498
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized, controlled trial is to determine if adding a protein-calorie supplement (PCS) to the standard treatments for tuberculosis (TB) and HIV will improve health outcomes. The investigators will enroll 180 HIV-positive women with newly diagnosed active TB and without prior anti-retroviral therapy (ART). At baseline, the investigators will conduct dietary interviews, measure body composition, randomize subjects to receive a PCS (plus micronutritional supplements \[MNS\]) or control (MNS only) for the 6-month duration of anti-TB therapy (ATT) plus an additional 2 mos (8 mos total). Subjects will be followed monthly and have CD4 counts at baseline, 2, 8 and 12 months. At 2 months (i.e., at the end of the 4 drug intensive phase of TB treatment and start of the 2 drug continuation phase), all subjects will be started on anti-retroviral therapy (ART) based on Tanzanian Ministry of Health guidelines (currently: AZT/3TC/efavirenz). The primary endpoint will be change in CD4 count after 8 months (i.e., at end of PCS/MNS intervention and 2 months after completion of ATT).

Conditions

HIV; Tuberculosis

Keywords

HIV; Tuberculosis; Nutrition

Outcome Measures

Primary Outcomes (1)

• Change in CD4 Count

  We will calculate change in CD4 count from start of ART until 6 mos on ART (which is started 2 mos after study enrollment, hence 8 mos after enrollment)

  Baseline to 8 months

Secondary Outcomes (2)

• BMI at 6 Months

  baseline to 6 months

• Number of Subjects Who Achieve 100 Cell Increase in CD4

  baseline to 8 months

Study Arms (2)

Protein calorie supplement plus micronutrient

ACTIVE COMPARATOR

Dietary Supplement: Protein calorie supplement

Micronutrient alone

PLACEBO COMPARATOR

Dietary Supplement: Micronutrient

Interventions

Protein calorie supplement DIETARY_SUPPLEMENT

Fortified porridge with 1062 kcal and 40 gm protein

Also known as: Dar-uji

Protein calorie supplement plus micronutrient

Micronutrient DIETARY_SUPPLEMENT

Dar-vite Multivitamin

Micronutrient alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female,
• HIV,
• age \> 18,
• CD4 \> 50,
• BMI\>16
• new TB diagnosis,
• not on anti-retroviral therapy,
• residence in Dar es Salaam

You may not qualify if:

• current anti-retroviral therapy,
• serious co-morbidities

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Infectious Disease Centre

Dar es Salaam, Tanzania

Location

Related Publications (1)

• Magohe A, Kimario J, Lukmanji Z, Hendricks K, Koethe JR, Neke NM, Tvaroha S, Connor R, Mackenzie T, Waddell R, Maro I, Matee M, Pallangyo K, Bakari M, Horsburgh CR, von Reyn CF. Randomized, controlled trial of a protein-calorie supplement for women coinfected with HIV-TB. Int J Tuberc Lung Dis. 2022 Aug 1;26(8):798-800. doi: 10.5588/ijtld.21.0669. No abstract available.

  PMID: 35898141 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Micronutrients

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Many patients were lost to follow-up which may interfere with the evaluation of treatment effects

Results Point of Contact

• Title: Dr C Fordham von Reyn
• Organization: Dartmouth-Hitchcock

fvr@dartmouth.edu

6036507167

Study Officials

• Charles F. von Reyn, MD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• Nyasule Majura-Neke, MD

  Muhimbili University of Health and Allied Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: Protein-calorie supplement plus micronutrient vs micronutrient alone

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: July 9, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)