NCT00197730

Brief Summary

The purpose of this study is to examine the effects of multivitamin (B, C, E) supplementation on reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,387

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Jun 2004

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

Enrollment Period

3.9 years

First QC Date

September 12, 2005

Last Update Submit

August 20, 2009

Conditions

HIV InfectionsPregnancy Complications

Keywords

Birth OutcomesNutritionHIVAIDSVitaminsMultivitaminsMaternal and child health outcomesTanzaniaAfrica

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality and diarrheal morbidity

    age 6 weeks to age 24 months

Secondary Outcomes (1)

  • Child growth faltering, lower respiratory infections, HIV breastfeeding transmission, and maternal HIV disease progression in relation to breastfeeding

    age 6 weeks to 24 months post partum

Study Arms (2)

Multivitamins

EXPERIMENTAL

Vitamin E, Vitamin C, and Vitamin B complex

Drug: Multivitamins - vitamins B complex, C and E

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Multivitamins - vitamins B complex, C and EDRUG

Age-appropriate dosages of vitamin C, vitamin E, thiamine, riboflavin, niacin, vitamin B6, folate, and vitamin B12 administered orally to children aged 6 weeks to 6 months, and two capsules per day for children aged older than 6 months for at least 12 months

Multivitamins
PlaceboDRUG

Placebo capsules administered orally once day orally to children aged 6 weeks to 6 months, and twice per day for children aged older than 6 months

Placebo

Eligibility Criteria

Age6 Weeks - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Related Publications (11)

  • Rees CA, Kisenge R, Manji KP, Liu E, Fawzi WW, Duggan CP. Identifying Infants and Young Children at Risk of Unplanned Hospital Admissions and Clinic Visits in Dar es Salaam, Tanzania. Pediatr Infect Dis J. 2020 Dec;39(12):e428-e434. doi: 10.1097/INF.0000000000002875.

    PMID: 32842043DERIVED

  • Blakstad MM, Smith ER, Etheredge A, Locks LM, McDonald CM, Kupka R, Kisenge R, Aboud S, Bellinger D, Sudfeld CR, Fawzi WW, Manji K, Duggan CP. Nutritional, Socioeconomic, and Delivery Characteristics Are Associated with Neurodevelopment in Tanzanian Children. J Pediatr. 2019 Apr;207:71-79.e8. doi: 10.1016/j.jpeds.2018.10.066. Epub 2018 Dec 14.

    PMID: 30559023DERIVED

  • Locks LM, Mwiru RS, Mtisi E, Manji KP, McDonald CM, Liu E, Kupka R, Kisenge R, Aboud S, Gosselin K, Gillman M, Gewirtz AT, Fawzi WW, Duggan CP. Infant Nutritional Status and Markers of Environmental Enteric Dysfunction are Associated with Midchildhood Anthropometry and Blood Pressure in Tanzania. J Pediatr. 2017 Aug;187:225-233.e1. doi: 10.1016/j.jpeds.2017.04.005. Epub 2017 May 9.

    PMID: 28499715DERIVED

  • Locks LM, Manji KP, Kupka R, Liu E, Kisenge R, McDonald CM, Aboud S, Wang M, Fawzi WW, Duggan CP. High Burden of Morbidity and Mortality but Not Growth Failure in Infants Exposed to but Uninfected with Human Immunodeficiency Virus in Tanzania. J Pediatr. 2017 Jan;180:191-199.e2. doi: 10.1016/j.jpeds.2016.09.040. Epub 2016 Nov 7.

    PMID: 27829511DERIVED

  • Sztam KA, Liu E, Manji KP, Kupka R, Kisenge R, Aboud S, Fawzi WW, Bosch RJ, Duggan CP. Maternal Antiretroviral Therapy Is Associated with Lower Risk of Diarrhea in Early Childhood. J Pediatr. 2016 Aug;175:54-60. doi: 10.1016/j.jpeds.2016.04.088. Epub 2016 May 28.

    PMID: 27245295DERIVED

  • Manji KP, Duggan C, Liu E, Bosch R, Kisenge R, Aboud S, Kupka R, Fawzi WW. Exclusive Breast-feeding Protects against Mother-to-Child Transmission of HIV-1 through 12 Months of Age in Tanzania. J Trop Pediatr. 2016 Aug;62(4):301-7. doi: 10.1093/tropej/fmw012. Epub 2016 Mar 15.

    PMID: 26999011DERIVED

  • Sudfeld CR, Duggan C, Aboud S, Kupka R, Manji KP, Kisenge R, Fawzi WW. Vitamin D status is associated with mortality, morbidity, and growth failure among a prospective cohort of HIV-infected and HIV-exposed Tanzanian infants. J Nutr. 2015 Jan;145(1):121-7. doi: 10.3945/jn.114.201566. Epub 2014 Nov 12.

    PMID: 25527666DERIVED

  • Sudfeld CR, Duggan C, Histed A, Manji KP, Meydani SN, Aboud S, Wang M, Giovannucci EL, Fawzi WW. Effect of multivitamin supplementation on measles vaccine response among HIV-exposed uninfected Tanzanian infants. Clin Vaccine Immunol. 2013 Aug;20(8):1123-32. doi: 10.1128/CVI.00183-13. Epub 2013 May 29.

    PMID: 23720367DERIVED

  • Kupka R, Manji KP, Bosch RJ, Aboud S, Kisenge R, Okuma J, Fawzi WW, Duggan C. Multivitamin supplements have no effect on growth of Tanzanian children born to HIV-infected mothers. J Nutr. 2013 May;143(5):722-7. doi: 10.3945/jn.112.170498. Epub 2013 Mar 20.

    PMID: 23514773DERIVED

  • Duggan C, Manji KP, Kupka R, Bosch RJ, Aboud S, Kisenge R, Okuma J, Fawzi WW. Multiple micronutrient supplementation in Tanzanian infants born to HIV-infected mothers: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2012 Dec;96(6):1437-46. doi: 10.3945/ajcn.112.044263. Epub 2012 Nov 7.

    PMID: 23134887DERIVED

  • McDonald CM, Kupka R, Manji KP, Okuma J, Bosch RJ, Aboud S, Kisenge R, Spiegelman D, Fawzi WW, Duggan CP. Predictors of stunting, wasting and underweight among Tanzanian children born to HIV-infected women. Eur J Clin Nutr. 2012 Nov;66(11):1265-76. doi: 10.1038/ejcn.2012.136. Epub 2012 Oct 3.

    PMID: 23031850DERIVED

MeSH Terms

Conditions

HIV InfectionsPregnancy ComplicationsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSlow Virus Diseases

Study Officials

  • Wafaie W Fawzi, MD, DrPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

TA(1)