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DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

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ClinicalTrials.gov Identifier: NCT01461863
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Low Birth Weight
Interventions Dietary Supplement: Porridge protein calorie supplement
Dietary Supplement: multivitamin
Enrollment 96
Recruitment Details Subjects recruited from HIV clinics in Dar es Salaam
Pre-assignment Details 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.
Arm/Group Title Protein Calorie Supplement Multivitamin
Hide Arm/Group Description

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

Standard multivitamin control

multivitamin: Standard multivitamin

Period Title: Overall Study
Started 48 48
Completed 48 48
Not Completed 0 0
Arm/Group Title Protein Calorie Supplement Multivitamin Total
Hide Arm/Group Description

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

Standard multivitamin control

multivitamin: Standard multivitamin

Total of all reporting groups
Overall Number of Baseline Participants 48 48 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
18 to 65 years Number Analyzed 48 participants 48 participants 96 participants
48
 100.0%
48
 100.0%
96
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 96 participants
Female
48
 100.0%
48
 100.0%
96
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 96 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
48
 100.0%
48
 100.0%
96
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Tanzania Number Analyzed 48 participants 48 participants 96 participants
48
 100.0%
48
 100.0%
96
 100.0%
1.Primary Outcome
Title Infant Weight
Hide Description Infant weight at 3 months
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Protein Calorie Supplement Multivitamin
Hide Arm/Group Description:

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

Standard multivitamin control

multivitamin: Standard multivitamin

Overall Number of Participants Analyzed 39 35
Mean (Standard Deviation)
Unit of Measure: kg
6.92  (0.82) 7.32  (1.32)
2.Secondary Outcome
Title Maternal BMI at 9 Months
Hide Description Maternal BMI at 9 months
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multivitamin Protein Calorie Supplement
Hide Arm/Group Description:
Multivitamin
[Not Specified]
Overall Number of Participants Analyzed 36 41
Median (Standard Error)
Unit of Measure: kg/m^2
24.3  (1.1) 23.8  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Protein Calorie Supplement Multivitamin
Hide Arm/Group Description

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

Standard multivitamin control

multivitamin: Standard multivitamin

All-Cause Mortality
Protein Calorie Supplement Multivitamin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/48 (2.08%)      1/48 (2.08%)    
Show Serious Adverse Events Hide Serious Adverse Events
Protein Calorie Supplement Multivitamin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/48 (2.08%)      1/48 (2.08%)    
Infections and infestations     
Death * [1]  1/48 (2.08%)  1 1/48 (2.08%)  1
*
Indicates events were collected by non-systematic assessment
[1]
HIV infection
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Protein Calorie Supplement Multivitamin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      4/48 (8.33%)    
Infections and infestations     
Infant HIV infection   0/48 (0.00%)  0 4/48 (8.33%)  4
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Charles Fordham von Reyn
Organization: Dartmouth-Hitchcock
Phone: 6036505000 ext 8840
Responsible Party: C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01461863     History of Changes
Other Study ID Numbers: R01HD057614-03 ( U.S. NIH Grant/Contract )
R01HD057614 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2011
First Posted: October 28, 2011
Results First Submitted: April 30, 2018
Results First Posted: August 14, 2018
Last Update Posted: August 14, 2018