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DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from HIV clinics in Dar es Salaam

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Protein Calorie Supplement   Multivitamin
STARTED   48   48 
COMPLETED   48   48 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Protein Calorie Supplement   Multivitamin   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   48   96 
Age, Customized 
[Units: Participants]
Count of Participants
     
18 to 65 years   48   48   96 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      48 100.0%      48 100.0%      96 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Tanzania   48   48   96 


  Outcome Measures

1.  Primary:   Infant Weight   [ Time Frame: 3 months ]

2.  Secondary:   Maternal BMI at 9 Months   [ Time Frame: 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: fvr@dartmouth.edu



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