Low Birth Weight
Conditions
Brief summary
This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health outcomes for HIV-infected pregnant women and their infants.
Detailed description
In resource poor regions of the world where HIV is endemic, especially countries in sub-Saharan Africa, nutrition plays a critical role in HIV disease. Nutrition affects the health of HIV-infected women and children, and may influence the risk of mother to infant transmission of HIV through breast milk. Nutrition influences the risk of tuberculosis (TB) and TB disease severity. Existing research has focused on the role of micronutrients in HIV disease outcomes but has not addressed the role of protein calorie supplementation (PCS) in subpopulations of patients with HIV disease at high risk, specifically, HIV-infected women who are either breast feeding or have active TB. Our hypotheses are that administration of a culturally acceptable PCS is a practical, sustainable and effective strategy to: 1) decrease HIV viral load in plasma and breast milk of breast feeding women, enhance passively transferred immune mediators in breast milk, and improve HIV outcomes in women and their breast-fed infants and, 2) decrease HIV viral load, enhance TB-specific T cell immunity, and improve outcomes in women with HIV and active TB.
Interventions
DIETARY_SUPPLEMENTPorridge protein calorie supplement
250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein
DIETARY_SUPPLEMENTmultivitamin
Standard multivitamin
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Muhimbili University of Health and Allied Sciences
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV+ women * 2nd trimester of pregnancy * Residency in Dar for duration of breastfeeding * Plan to exclusively breastfeed
Exclusion criteria
* High risk pregnancy (e.g., diabetes, pre-eclampsia) * Women with allergy to components of PCS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Weight | 3 months | Infant weight at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal BMI at 9 Months | 9 months | Maternal BMI at 9 months |
Countries
Tanzania
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 48 |
| Multivitamin Standard multivitamin control
multivitamin: Standard multivitamin | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | Protein Calorie Supplement | Total | Multivitamin |
|---|---|---|---|
| Age, Customized 18 to 65 years | 48 Participants | 96 Participants | 48 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 96 Participants | 48 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Tanzania | 48 Participants | 96 Participants | 48 Participants |
| Sex: Female, Male Female | 48 Participants | 96 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 48 | 1 / 48 |
| other Total, other adverse events | 0 / 48 | 4 / 48 |
| serious Total, serious adverse events | 1 / 48 | 1 / 48 |
Outcome results
Primary
Infant Weight
Infant weight at 3 months
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Protein Calorie Supplement | Infant Weight | 6.92 kg | Standard Deviation 0.82 |
| Multivitamin | Infant Weight | 7.32 kg | Standard Deviation 1.32 |
Secondary
Maternal BMI at 9 Months
Maternal BMI at 9 months
Time frame: 9 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Protein Calorie Supplement | Maternal BMI at 9 Months | 24.3 kg/m^2 | Standard Error 1.1 |
| Multivitamin | Maternal BMI at 9 Months | 23.8 kg/m^2 | Standard Error 1.1 |