Trial Outcomes & Findings for DarDar Nutrition Study in HIV Breastfeeding Women (NCT NCT01461863)

NCT ID: NCT01461863

Last Updated: 2018-08-14

Results Overview

Infant weight at 3 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-08-14

Participant Flow

Subjects recruited from HIV clinics in Dar es Salaam

Eligibility required that the woman be free of acute illness, have a BMI ≥18.5 kg/m2 and intend to exclusively breastfeed her infant for at least 3 months.

Participant milestones

Measure	Protein Calorie Supplement 250 gm daily of specially designed porridge plus standard multivitamin Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein	Multivitamin Standard multivitamin control multivitamin: Standard multivitamin
Overall Study STARTED	48	48
Overall Study COMPLETED	48	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DarDar Nutrition Study in HIV Breastfeeding Women

Baseline characteristics by cohort

Measure	Protein Calorie Supplement n=48 Participants 250 gm daily of specially designed porridge plus standard multivitamin Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein	Multivitamin n=48 Participants Standard multivitamin control multivitamin: Standard multivitamin	Total n=96 Participants Total of all reporting groups
Age, Customized 18 to 65 years	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Tanzania	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Infant weight at 3 months

Outcome measures

Measure	Protein Calorie Supplement n=39 Participants 250 gm daily of specially designed porridge plus standard multivitamin Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein	Multivitamin n=35 Participants Standard multivitamin control multivitamin: Standard multivitamin
Infant Weight	6.92 kg Standard Deviation 0.82	7.32 kg Standard Deviation 1.32

SECONDARY outcome

Timeframe: 9 months

Maternal BMI at 9 months

Outcome measures

Measure	Protein Calorie Supplement n=36 Participants 250 gm daily of specially designed porridge plus standard multivitamin Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein	Multivitamin n=41 Participants Standard multivitamin control multivitamin: Standard multivitamin
Maternal BMI at 9 Months	24.3 kg/m^2 Standard Error 1.1	23.8 kg/m^2 Standard Error 1.1

Adverse Events

Protein Calorie Supplement

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Multivitamin

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Protein Calorie Supplement n=48 participants at risk 250 gm daily of specially designed porridge plus standard multivitamin Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein	Multivitamin n=48 participants at risk Standard multivitamin control multivitamin: Standard multivitamin
Infections and infestations Death	2.1% 1/48 • Number of events 1	2.1% 1/48 • Number of events 1

Other adverse events

Measure	Protein Calorie Supplement n=48 participants at risk 250 gm daily of specially designed porridge plus standard multivitamin Porridge protein calorie supplement: 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein	Multivitamin n=48 participants at risk Standard multivitamin control multivitamin: Standard multivitamin
Infections and infestations Infant HIV infection	0.00% 0/48	8.3% 4/48 • Number of events 4

Additional Information

Dr. Charles Fordham von Reyn

Dartmouth-Hitchcock

Phone: 6036505000

Email: fvr@dartmouth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place