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: April 9, 2013

Last verified: April 2013

History of Changes

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:

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%?
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%?
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%?
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:

MedlinePlus related topics: Breast Feeding HIV/AIDS Postpartum Care Vitamin A

Drug Information available for: Retinol Vitamin A palmitate Vitamin A

U.S. FDA Resources

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 2015
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
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

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:

Zijenah LS, Humphrey J, Nathoo K, Malaba L, Zvandasara P, Mahomva A, Iliff P, Mbizvo MT. Evaluation of the prototype Roche DNA amplification kit incorporating the new SSK145 and SKCC1B primers in detection of human immunodeficiency virus type 1 DNA in Zimbabwe. J Clin Microbiol. 1999 Nov;37(11):3569-71.

Zijenah LS, Moulton LH, Iliff P, Nathoo K, Munjoma MW, Mutasa K, Malaba L, Zvandasara P, Ward BJ, Humphrey J; ZVITAMBO Study Group. Timing of mother-to-child transmission of HIV-1 and infant mortality in the first 6 months of life in Harare, Zimbabwe. AIDS. 2004 Jan 23;18(2):273-80.

Malaba LC, Iliff PJ, Nathoo KJ, Marinda E, Moulton LH, Zijenah LS, Zvandasara P, Ward BJ, Humphrey JH; the ZVITAMBO Study Group. Effect of postpartum maternal or neonatal vitamin A supplementation on infant mortality among infants born to HIV-negative mothers in Zimbabwe. Am J Clin Nutr. 2005 Feb;81(2):454-60.

Iliff PJ, Piwoz EG, Tavengwa NV, Zunguza CD, Marinda ET, Nathoo KJ, Moulton LH, Ward BJ, Humphrey JH; ZVITAMBO study group. Early exclusive breastfeeding reduces the risk of postnatal HIV-1 transmission and increases HIV-free survival. AIDS. 2005 Apr 29;19(7):699-708.

Piwoz EG, Iliff PJ, Tavengwa N, Gavin L, Marinda E, Lunney K, Zunguza C, Nathoo KJ, Humphrey JH. An education and counseling program for preventing breast-feeding-associated HIV transmission in Zimbabwe: design and impact on maternal knowledge and behavior. J Nutr. 2005 Apr;135(4):950-5.

Miller MF, Stoltzfus RJ, Mbuya NV, Malaba LC, Iliff PJ, Humphrey JH; ZVITAMBO Study Group. Total body iron in HIV-positive and HIV-negative Zimbabwean newborns strongly predicts anemia throughout infancy and is predicted by maternal hemoglobin concentration. J Nutr. 2003 Nov;133(11):3461-8.

Humphrey JH, Rice AL. Vitamin A supplementation of young infants. Lancet. 2000 Jul 29;356(9227):422-4.

Humphrey J, Iliff P. Is breast not best? Feeding babies born to HIV-positive mothers: bringing balance to a complex issue. Nutr Rev. 2001 Apr;59(4):119-27. Review.

Miller M, Humphrey J, Johnson E, Marinda E, Brookmeyer R, Katz J. Why do children become vitamin A deficient? J Nutr. 2002 Sep;132(9 Suppl):2867S-2880S.

Miller M, Iliff P, Stoltzfus RJ, Humphrey J. Breastmilk erythropoietin and mother-to-child HIV transmission through breastmilk. Lancet. 2002 Oct 19;360(9341):1246-8.

Stoltzfus RJ, Humphrey JH. Vitamin A and the nursing mother-infant dyad: evidence for intervention. Adv Exp Med Biol. 2002;503:39-47. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Humphrey JH, Marinda E, Mutasa K, Moulton LH, Iliff PJ, Ntozini R, Chidawanyika H, Nathoo KJ, Tavengwa N, Jenkins A, Piwoz EG, Van de Perre P, Ward BJ; ZVITAMBO study group. Mother to child transmission of HIV among Zimbabwean women who seroconverted postnatally: prospective cohort study. BMJ. 2010 Dec 22;341:c6580.

Hargrove JW, Humphrey JH; ZVITAMBO Study Group. Mortality among HIV-positive postpartum women with high CD4 cell counts in Zimbabwe. AIDS. 2010 Jan 28;24(3):F11-4.

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:	April 9, 2013
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
Vitamin A
Vitamins
Retinol palmitate

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013

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