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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD057614 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Muhimbili University of Health and Allied Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| protein calorie supplement | Active Comparator | 250 gm daily of specially designed porridge plus standard multivitamin |
|
| Multivitamin | Placebo Comparator | Standard multivitamin control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porridge protein calorie supplement | Dietary Supplement | 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant Weight | Infant weight at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal BMI at 9 Months | Maternal BMI at 9 months | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C. Fordham von Reyn, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhimbili University of Health and Allied Sciences | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30307945 | Derived | Magohe A, Mackenzie T, Kimario J, Lukmanji Z, Hendricks K, Koethe J, Neke NM, Tvaroha S, Connor R, Waddell R, Maro I, Matee M, Pallangyo K, Bakari M, von Reyn CF; DarDar-2 Study Team. Pre- and post-natal macronutrient supplementation for HIV-positive women in Tanzania: Effects on infant birth weight and HIV transmission. PLoS One. 2018 Oct 11;13(10):e0201038. doi: 10.1371/journal.pone.0201038. eCollection 2018. |
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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.
Subjects recruited from HIV clinics in Dar es Salaam
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Multivitamin | Standard multivitamin control multivitamin: Standard multivitamin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Multivitamin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Weight | Infant weight at 3 months | Posted | Mean | Standard Deviation | kg | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Infections and infestations | Non-systematic Assessment | HIV infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infant HIV infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Fordham von Reyn | Dartmouth-Hitchcock | 6036505000 | 8840 | fvr@dartmouth.edu |
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| ID | Term |
|---|---|
| C067316 | Geritol |
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|
| multivitamin | Dietary Supplement | Standard multivitamin |
|
|
Standard multivitamin control multivitamin: Standard multivitamin |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
|
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| Secondary | Maternal BMI at 9 Months | Maternal BMI at 9 months | Posted | Median | Standard Error | kg/m^2 | 9 months |
|
|
|
| 1 |
| 48 |
| 1 |
| 48 |
| 0 |
| 48 |
| EG001 | Multivitamin | Standard multivitamin control multivitamin: Standard multivitamin | 1 | 48 | 1 | 48 | 4 | 48 |
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