DarDar Nutrition Study in HIV Breastfeeding Women

NCT ID: NCT01461863

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Low Birth Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

protein calorie supplement

250 gm daily of specially designed porridge plus standard multivitamin

Group Type: ACTIVE_COMPARATOR

Porridge protein calorie supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Multivitamin

Standard multivitamin control

Group Type: PLACEBO_COMPARATOR

multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Standard multivitamin

Interventions

Porridge protein calorie supplement

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

Intervention Type: DIETARY_SUPPLEMENT

multivitamin

Standard multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Dar-uji; Darvite

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

C. Fordham von Reyn

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C. Fordham von Reyn, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Muhimbili University of Health and Allied Sciences

Dar es Salaam, , Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 30307945 (View on PubMed)

Other Identifiers

R01HD057614

Identifier Type: NIH

Identifier Source: secondary_id

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R01HD057614-03

Identifier Type: NIH

Identifier Source: org_study_id

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