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Completed

NCT Number: NCT01461863

DarDar Nutrition Study in HIV Breastfeeding Women

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Porridge protein calorie supplement

Dietary Supplement

250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein

Other names: Dar-uji

Multivitamin

Dietary Supplement

Standard multivitamin

Other names: Darvite

Primary outcomes

  1. Infant Weight

    Time frame: 3 months

    Infant weight at 3 months

Secondary outcomes

  1. Maternal BMI at 9 Months

    Time frame: 9 months

    Maternal BMI at 9 months

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Muhimbili University of Health and Allied Sciences

Registry information

Official study title

Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women

Acronym: DarDar2B

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 28, 2011
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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