Trial Outcomes & Findings for Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis (NCT NCT01635153)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

151 participants

Primary outcome timeframe

Baseline to 8 months

Results posted on

2020-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Protein Calorie Supplement Plus Micronutrient Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein	Micronutrient Alone Micronutrient: Dar-vite Multivitamin
Overall Study STARTED	72	79
Overall Study COMPLETED	32	36
Overall Study NOT COMPLETED	40	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Protein Calorie Supplement Plus Micronutrient Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein	Micronutrient Alone Micronutrient: Dar-vite Multivitamin
Overall Study Lost to Follow-up	40	43

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Protein Calorie Supplement Plus Micronutrient n=72 Participants Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein	Micronutrient Alone n=79 Participants Micronutrient: Dar-vite Multivitamin	Total n=151 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=5 Participants	79 Participants n=7 Participants	151 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.5 years n=5 Participants	36 years n=7 Participants	37 years n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	79 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Tanzania	72 participants n=5 Participants	79 participants n=7 Participants	151 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 months

Population: Women with newly diagnosed TB and newly diagnosed HIV, not on ART

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)

Outcome measures

Outcome measures
Measure	Protein Calorie Supplement Plus Micronutrient n=72 Participants Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein	Micronutrient Alone n=79 Participants Micronutrient: Dar-vite Multivitamin
Change in CD4 Count	215 increase in CD4 cells/mm^3 Standard Deviation 28	174 increase in CD4 cells/mm^3 Standard Deviation 21

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Women with newly diagnosed TB and newly diagnosed HIV not on ART

BMI will be compared between the two treatment groups

Outcome measures

Outcome measures
Measure	Protein Calorie Supplement Plus Micronutrient n=72 Participants Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein	Micronutrient Alone n=79 Participants Micronutrient: Dar-vite Multivitamin
BMI at 6 Months	25.4 kg/m^2 Standard Deviation 5.73	24.7 kg/m^2 Standard Deviation 4.99

SECONDARY outcome

Timeframe: baseline to 8 months

Population: Women with newly diagnosed TB and newly diagnosed HIV not yet on ART

Number of subjects in 2 treatment groups who achieve 100 cell increase in CD4 will be compared

Outcome measures

Outcome measures
Measure	Protein Calorie Supplement Plus Micronutrient n=72 Participants Protein calorie supplement: Fortified porridge with 1062 kcal and 40 gm protein	Micronutrient Alone n=79 Participants Micronutrient: Dar-vite Multivitamin
Number of Subjects Who Achieve 100 Cell Increase in CD4	25 N of subjects with CD4 increase of ≥100	26 N of subjects with CD4 increase of ≥100

Adverse Events

Protein Calorie Supplement Plus Micronutrient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Micronutrient Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr C Fordham von Reyn

Dartmouth-Hitchcock

Phone: 6036507167

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place