Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Single-dose Postpartum Vitamin A Supplementation of Mothers and Neonates (ZVITAMBO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
McGill University Health Center
University of Zimbabwe
Harare City Health Department, Harare, Zimbabwe
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Rockefeller Foundation
BASF
SARA and Linkages Projects, Academy for Educational Development, Washington DC.
Université de Montréal
Information provided by (Responsible Party):
Jean Humphrey, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00198718
First received: September 12, 2005
Last updated: September 16, 2015
Last verified: September 2015
  Purpose

The ZVITAMBO PROJECT is testing whether giving mothers and infants a single large dose of vitamin A during the immediate post partum period will reduce:

  1. Infant Mortality Can oral administration of a single 50,000 IU dose of vitamin A to newborn infants, a single 400,000 IU dose of vitamin A given to their lactating mothers, or supplementation of both the mother and infant during the immediate post partum period reduce infant mortality by at least 30%?
  2. Mother to Child HIV transmission during breast feeding Can oral administration of a single large dose of vitamin A given during the immediate post partum period to HIV seropositive lactating women and/or their babies reduce HIV transmission via breast feeding by at least 30%?
  3. Sexually transmitted HIV infection of post partum women Can a single 400,000 IU dose of vitamin A given during the immediate post partum period to HIV seronegative women reduce their likelihood of becoming HIV infected during the post partum year by at least 25%?
  4. Infant feeding in the context of HIV: An operational research study was initiated mid-way through the trial to determine how UNAIDS Guidelines on infant feeding in the context of HIV could be effectively implemented and to measure the impact of such a program on infant feeding practices and postnatal HIV transmission.

Substudies:

Random subsamples of maternal and infant blood were evaluated for anemia and iron status to determine the effect of vitamin A on hematopoiesis and serum and breast milk retinol (mothers) and modified relative dose response test (infants) to determine the effect of vitamin A on vitamin A status.

A subsample of maternal and infant blood samples were evaluated for the presence of HLA-E, HLA-G, and TAP polymorphisms and their relation to prevalent HIV infection in mothers and risk of mother to child transmission.


Condition Intervention Phase
Vitamin A Deficiency
HIV
Drug: Vitamin A (retinyl palmitate)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin A Supplementation of Breast Feeding Mothers and Their Neonates at Delivery: Impact on Mother to Child Transmission of HIV During Lactation, HIV Infection Among Women During the Postpartum Year, and Infant Mortality.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 1. HIV infection rate among baseline HIV-negative babies born to HIV-positive mothers at 24 months [ Time Frame: By 24 months of age ] [ Designated as safety issue: No ]
  • 2. Infant mortality rate among all infants, infants born to HIV-negative mothers, and infants born to HIV-positive mothers at 6 months [ Time Frame: by 12 months of age ] [ Designated as safety issue: No ]
  • 3. HIV infection rates among baseline HIV-negative mothers at 24 months [ Time Frame: by 24 months postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. HIV infection or death rate among baseline HIV-negative babies born to HIV-positive mothers at 6, 12, and 18 months [ Time Frame: By 24 months of age ] [ Designated as safety issue: No ]
  • 2. HIV infection or death rate among 6-wk HIV-negative babies born to HIV-positive mothers at 6, 12, 18, 24 months [ Time Frame: by 24 months of age ] [ Designated as safety issue: No ]
  • 3. Serum and breast milk retinol concentration among women at 12 months [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]
  • 4. Modified relative dose response ratios among infants at 6 wk, and 3, 6, 9, and 12 months. [ Time Frame: 12 months post partum ] [ Designated as safety issue: No ]
  • 5. Viral load among HIV-positive women at 6 wk, and 3, 6, 9, and 12 months. [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]
  • 6. Weight for age among infants at 12 months [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
  • 7. Weight for length among infants at 12 months [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
  • 8. Length for age among infants at 12 months [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]

Enrollment: 28220
Study Start Date: November 1997
Estimated Study Completion Date: May 2016
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infant vitamin A Mother vitamin A
Infant received 50,000 IU vitamin A, mother received 400,000 IU vitamin A
Drug: Vitamin A (retinyl palmitate)
Experimental: Infant vitamin A Mother placebo
Infant received 50,000 IU vitamin A, mother received placebo
Drug: Vitamin A (retinyl palmitate)
Experimental: Infant placebo, mother vitamin A
Infant received placebo, mother received 400,000 IU vitamin A
Drug: Vitamin A (retinyl palmitate)
Experimental: Infant received placebo, mother received placebo
Infant and mother received placebo
Drug: Vitamin A (retinyl palmitate)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mothers and their neonates delivering at a study recruitment site during the recruitment period

Exclusion Criteria:

  • mother in intensive care unit
  • mother not fully conscious
  • maternal temperature > 39˚
  • Mother is 'nil per mouth' (NPO)
  • Mother is terminally ill as indicated in medical notes
  • Infant is NPO
  • Infant is terminally ill as indicated in medical notes
  • Infant birth weight <1500 g
  • Infant is a twin or triplet delivery
  • Regular place of residence is outside Harare.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198718

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
McGill University Health Center
University of Zimbabwe
Harare City Health Department, Harare, Zimbabwe
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Rockefeller Foundation
BASF
SARA and Linkages Projects, Academy for Educational Development, Washington DC.
Université de Montréal
Investigators
Principal Investigator: Jean H Humphrey, ScD Johns Hopkins Bloomberg School of Pubic Health
  More Information

Publications:
Iliff PJ, Humphrey JH, Mahomva AI, Zvandasara P, Bonduelle M, Malaba LC, Nathoo KJ. Tolerance of large doses of vitamin A given to mothers and their babies shortly after delivery. Nutr Res 1999; 19 (10): 1437-1446.
Humphrey JH and Ichord RN: Safety of vitamin A supplementation of postpartum women and young children. Food and Nutrition Bulletin (2001) 22: 311-319.
Humphrey JH, Iliff PJ, Marinda E, Mutasa K, Moulton LH, Chidawanyika H, Ward BJ, Nathoo KJ, Malaba LC, Zijenah LS, Zvandasara P, Ntozini R, Mzengeza F, Mahomva A, Ruff A, Mbizvo M, Zunguza C, and the ZVITAMBO Study Group: Impact of single large doses of vitamin A given during the postpartum period to HIV-infected women and their neonates on breastfeeding-associated mother-to-child-transmission of HIV and infant mortality in Zimbabwe. J Infectious Diseases 2006, 193:860-871. Selected for an editorial: Fawzi, WW: The benefits and concerns related to vitamin A supplementation. J Infectious Diseases 2006;193:756-9.
Lunney KM,* Iliff P, Mutasa K, Ntozini R, Magder LS, Moulton LH, Humphrey JH. Associations between breast milk viral load, mastitis, exclusive breast-feeding, and postnatal transmission of HIV. Clin Infect Dis. 2010 Mar 1;50(5):762-9.Selected for an editorial: Kuhn L. Milk mysteries: Why are women who exclusively breast-feed less likely to transmit HIV during breast-feeding? Clin Inf Dis (2010) 50:770-772.
Koyanagi A,* Humphrey JH, Moulton LH, Ntozini R, Mutasa K, Iliff P, Ruff AJ, and the ZVITAMBO Study Group. Predictors of postpartum weight loss and predictive value of weight loss on maternal mortality in HIV-positive women of prolonged breastfeeding setting. AIDS Research and Human Retroviruses: DOI: 10.1089/AID.2010.0293

Responsible Party: Jean Humphrey, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00198718     History of Changes
Other Study ID Numbers: (CIDA) (R/C Project 690/M3688) 
Study First Received: September 12, 2005
Last Updated: September 16, 2015
Health Authority: United States: Institutional Review Board
Zimbabwe: Medical Research Council
Canada: Ethical Review Board of the Research Institute of McGill University Health Centers

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Vitamin A supplementation
HIV
Mother to child transmission of HIV
Breastfeeding

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016