Maternal and Child Health OutcomesNCT00197756
Vitamins, Breastmilk HIV Shedding, and Child Health
An observational study of Maternal and Child Health Outcomes, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy on a number of parameters in breastmilk. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal and Child Health Outcomes
- What is being tested?
- Vitamin A alone, Multivitamins excluding vitamin A and multivitamins including vitamin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 771 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The data and samples used in this study are from HIV-infected pregnant women who participated in the "Trial of Vitamins in HIV Transmission and Progression". Between 1995 and 1997, 1,078 African, HIV positive women who were between gestatopm weeks 12 and 27 were recruited. They were followed until August 2003. This study was conducte among 771 of these women, for whom breast milk samples were available at delivery. There were no differences in baseline characteristics between this subset and the originally randomized group of 1,069.
This study is analyzing samples previously collected from the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257).
The inclusion criteria in this study was:
- HIV infected women presenting to antenatal care between 12 and 27 weeks of gestation
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Public Health
Boston, Massachusetts, 02115
About this study
The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy on a number of parameters in breastmilk.
Read the detailed description
The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy
- Conditions
- Maternal and Child Health Outcomes
- Being tested
- Vitamin A alone, Multivitamins excluding vitamin A, multivitamins including vitamin A, Placebo
- Keywords
- HIV, Breastfeeding, Vitamins, Tanzania, Children
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A aloneDietary supplement
30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
Multivitamins excluding vitamin ADietary supplement
30 mg thiamine, 20 mg riboflavin, 20 mg B-6, 100 mg niacin, 50 ug vitamin B-12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid taken orally once per day during pregnancy and lactation
multivitamins including vitamin ADietary supplement
20 mg thiamine, 20 mg riboflavin, 25 mg vitamin B6, 100 mg niacin, 50 ug vitamin B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid taken once per day orally during pregnancy and lactation
PlaceboOther
Placebo pill taken orally once per day during pregnancy and lactation
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A | Participants in the in the parent study who had been randomized to receive either Vitamin A alone or multivitamins including vitamin A. Receives: Dietary Supplement: Vitamin A alone | |
| No Vitamin A | Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo. Receives: Dietary Supplement: Multivitamins excluding vitamin A; Dietary Supplement: multivitamins including vitamin A; Other: Placebo | |
| Multivitamins | Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A Receives: Dietary Supplement: Vitamin A alone; Dietary Supplement: Multivitamins excluding vitamin A; Dietary Supplement: multivitamins including vitamin A | |
| No Multivitamins | Participants from the parent study who had been randomized to vitamin A alone or placebo Receives: Dietary Supplement: Vitamin A alone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cell-free viral load and/or cell-associated proviral load in breast milk
Measured: Delivery, 3 months, and 6 months after delivery
concentration of vitamins A, B12, and E in breast milk
Measured: Delivery, 3 months, and 6 months post-delivery
subclinical mastitis
Measured: Delivery, 3 months, and 6 months after delivery
Secondary outcomes (4)
post-natal mother-to-child transmission of HIV
Measured: Delivery, 3 months, and 6 months post-delivery
infant mortality and morbidity from diarrhea
Measured: Delivery, 3 months and 6 months after delivery
a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages
Measured: N/A (in vitro experiment)
HIV-1 replication in differentiating monocytes acutely infected with a subtype C HIV-1 clone, differentiated non-dividing MDMs acutely infected with the HIV-1 MJ4 clone, and differentiated non-dividing MDMs chronically infected with the HIV-1 MJ4 clone.
Measured: N/A (in vitro experiment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal and Child Health OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Investigators
- Eduardo Villamor, MD,DrPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197756
- Sponsor's protocol ID
- HD45134
- Status last verified
- Aug 2009
- First submitted
- 12 Sep 2005
- Last updated
- 21 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Villamor E, Koulinska IN, Aboud S, Murrin C, Bosch RJ, Manji KP, Fawzi WW. Effect of vitamin supplements on HIV shedding in breast milk. Am J Clin Nutr. 2010 Oct;92(4):881-6. doi: 10.3945/ajcn.2010.29339. Epub 2010 Aug 25.
PubMed 20739426Webb AL, Aboud S, Furtado J, Murrin C, Campos H, Fawzi WW, Villamor E. Effect of vitamin supplementation on breast milk concentrations of retinol, carotenoids and tocopherols in HIV-infected Tanzanian women. Eur J Clin Nutr. 2009 Mar;63(3):332-9. doi: 10.1038/sj.ejcn.1602929. Epub 2007 Oct 17.
PubMed 17940544
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamins, Breastmilk HIV Shedding, and Child Health
- ClinicalTrials.gov ID
- NCT00197756
- Acronym / sponsor ID
- HD45134
- Conditions
- Maternal and Child Health Outcomes
- Keywords
- HIV, Breastfeeding, Vitamins, Tanzania, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Sep 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy on a number of parameters in breastmilk.
Detailed description
The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | – | Dietary Supplement: Vitamin A aloneParticipants in the in the parent study who had been randomized to receive either Vitamin A alone or multivitamins including vitamin A. |
| No Vitamin A | – | Dietary Supplement: Multivitamins excluding vitamin A, Dietary Supplement: multivitamins including vitamin A, Other: PlaceboParticipants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo. |
| Multivitamins | – | Dietary Supplement: Vitamin A alone, Dietary Supplement: Multivitamins excluding vitamin A, Dietary Supplement: multivitamins including vitamin AParticipants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A |
| No Multivitamins | – | Dietary Supplement: Vitamin A alone, Other: PlaceboParticipants from the parent study who had been randomized to vitamin A alone or placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data and samples used in this study are from HIV-infected pregnant women who participated in the "Trial of Vitamins in HIV Transmission and Progression". Between 1995 and 1997, 1,078 African, HIV positive women who were between gestatopm weeks 12 and 27 were recruited. They were followed until August 2003. This study was conducte among 771 of these women, for whom breast milk samples were available at delivery. There were no differences in baseline characteristics between this subset and the originally randomized group of 1,069.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A alone30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation | Dietary supplement | Multivitamins, No Multivitamins, Vitamin A |
| Multivitamins excluding vitamin A30 mg thiamine, 20 mg riboflavin, 20 mg B-6, 100 mg niacin, 50 ug vitamin B-12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid taken orally once per day during pregnancy and lactation | Dietary supplement | Multivitamins, No Vitamin A |
| multivitamins including vitamin A20 mg thiamine, 20 mg riboflavin, 25 mg vitamin B6, 100 mg niacin, 50 ug vitamin B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid taken once per day orally during pregnancy and lactation | Dietary supplement | Multivitamins, No Vitamin A |
| PlaceboPlacebo pill taken orally once per day during pregnancy and lactation | Other | No Multivitamins, No Vitamin A |
Primary outcome
cell-free viral load and/or cell-associated proviral load in breast milk
Time frame: Delivery, 3 months, and 6 months after delivery
concentration of vitamins A, B12, and E in breast milk
Time frame: Delivery, 3 months, and 6 months post-delivery
subclinical mastitis
Time frame: Delivery, 3 months, and 6 months after delivery
4 secondary outcomes
post-natal mother-to-child transmission of HIV
Time frame: Delivery, 3 months, and 6 months post-delivery
infant mortality and morbidity from diarrhea
Time frame: Delivery, 3 months and 6 months after delivery
a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages
Time frame: N/A (in vitro experiment)
HIV-1 replication in differentiating monocytes acutely infected with a subtype C HIV-1 clone, differentiated non-dividing MDMs acutely infected with the HIV-1 MJ4 clone, and differentiated non-dividing MDMs chronically infected with the HIV-1 MJ4 clone.
Time frame: N/A (in vitro experiment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2009.
- Derived from this study: PubMed 20739426Villamor E, Koulinska IN, Aboud S, Murrin C, Bosch RJ, Manji KP, Fawzi WW. Effect of vitamin supplements on HIV shedding in breast milk. Am J Clin Nutr. 2010 Oct;92(4):881-6. doi: 10.3945/ajcn.2010.29339. Epub 2010 Aug 25.
- Derived from this study: PubMed 17940544Webb AL, Aboud S, Furtado J, Murrin C, Campos H, Fawzi WW, Villamor E. Effect of vitamin supplementation on breast milk concentrations of retinol, carotenoids and tocopherols in HIV-infected Tanzanian women. Eur J Clin Nutr. 2009 Mar;63(3):332-9. doi: 10.1038/sj.ejcn.1602929. Epub 2007 Oct 17.
Related trials for Maternal and Child Health Outcomes
Enrolling by invitation
MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use
Substance Use Disorders, Parent-Child Relations
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
RecruitingObservational study
Maternal Cancer Diagnosis and Treatment During Pregnancy:a Database for Maternal, Fetal, and Neonatal Outcomes
Pregnancy, Cancer, Cancer in Pregnancy, Gestational Breast Cancer, Pregnancy Related
RecruitingObservational study
Maternal Iron Deficiency and Childhood Health
Iron Deficiency Anaemia in Childbirth, Iron Deficiency
Active, not recruiting
Enhancing Intergenerational Health in Nigeria: Peripartum as Critical Life Stage for Cardiovascular Health
Hypertension in Pregnancy, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Villamor, MD,DrPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal and Child Health Outcomes, run by Harvard School of Public Health (HSPH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cell-free viral load and/or cell-associated proviral load in breast milk (time frame: Delivery, 3 months, and 6 months after delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197756, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2009.