Mortality Through Six Months of AgePhase 3NCT00128557
Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
A Phase 3 study testing vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU) in people with Mortality Through Six Months of Age and Vitamin A Deficiency, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
Trial summary
The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. Read more about this study
- Who is it for?
- Ages 1 minute to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Mortality Through Six Months of Age, Vitamin A Deficiency
- What is being tested?
- vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15,937 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2004to Dec 2006
- Phase
- Phase 3
- 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 1 minute to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: Infants born to women enrolled in a maternal supplementation trial, alive and less than 30 days of age during a newborn dosing visit Exclusion Criteria: Infants who died before the dose could be administered or infants older than 30 days at the time of dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.
Read the detailed description
This is a randomized, double-masked, placebo-controlled, community trial of newborn vitamin A supplementation on mortality in the first six months of life. The trial is being implemented in 596 sectors (i.e. villages and/or smaller groupings), in two thanas comprising a population of ~580,000 in rural northern Bangladesh (Gaibandha/Rangpur area) and is nested within the JiVitA-1 maternal supplementation study. Women residing in the study area are already under 5-weekly pregnancy surveillance conducted by village-based field staff as part of the maternal supplementation trial. During their third trimester of pregnancy, women are visited by a study supervisor who explains the purpose and procedures of the study. After obtaining informed consent, women are interviewed for possible risk factors in the third trimester of pregnancy, including a 30-day history of morbidity, a 7-day dietary and alcohol intake and tobacco use questionnaire, a 7-day household chores questionnaire, and maternal anthropometry (mid upper arm circumference measurement). Upon birth, household members contact the village-based field staff who immediately administers the vitamin A or placebo to the infant, according to sector assignment. After supplementation, newborns are measured for weight, length and mid-upper arm, head and chest circumference, and then followed weekly for vital status for three months, and again at six months of age. A child death initiates the process of death verification and cause of death determination.
- Being tested
- vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)
- Keywords
- Vitamin A, Newborn health, Infant Mortality, Supplementation, Micronutrients, Bangladesh
- Medical subject headings
- Vitamin A Deficiency, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)Dietary supplement
Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Supplement containing soybean oil with a small amount of vitamin E as an antioxidant Receives: Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU) |
| Vitamin A | Active comparator | 15,000 ug retinol equivalents (50,000 International Units) Receives: Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-week infant mortality rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2006
- Study completionDec 2006
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 Mortality Through Six Months of AgeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 15,937 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Johns Hopkins University, Bill and Melinda Gates Foundation, Canadian International Development Agency, Access Business Group
- Responsible party
- Sponsor
- Investigators
- Rolf DW Klemm, Dr PH, Principal investigator, Johns Hopkins UniversityKeith P West, Jr., Dr. P.H., Study director, Johns Hopkins Bloomberg School of Public HealthParul Christian, Dr. P.H., Study director, Johns Hopkins Bloomberg School of Public HealthMahbubar Rashid, MBBS, MSc, MBA, Study director, JiVitA Bangladesh ProjectAlain B. Labrique, MSc, Study director, Johns Hopkins Bloomberg School of Public HealthAlfred Sommer, M.D., Study director, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128557
- Sponsor's protocol ID
- H.22.03.01.09.A2
- Status last verified
- Apr 2007
- First submitted
- 9 Aug 2005
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ali H, Hamadani J, Mehra S, Tofail F, Hasan MI, Shaikh S, Shamim AA, Wu LS, West KP Jr, Christian P. Effect of maternal antenatal and newborn supplementation with vitamin A on cognitive development of school-aged children in rural Bangladesh: a follow-up of a placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Jul;106(1):77-87. doi: 10.3945/ajcn.116.134478. Epub 2017 May 10.
PubMed 28490513Coles CL, Labrique A, Saha SK, Ali H, Al-Emran H, Rashid M, Christian P, West KP Jr, Klemm R. Newborn vitamin A supplementation does not affect nasopharyngeal carriage of Streptococcus pneumoniae in Bangladeshi infants at age 3 months. J Nutr. 2011 Oct;141(10):1907-11. doi: 10.3945/jn.111.141622. Epub 2011 Aug 10.
PubMed 21832026
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT00128557
- Acronym / sponsor ID
- H.22.03.01.09.A2
- Keywords
- Vitamin A, Newborn health, Infant Mortality, Supplementation, Micronutrients, Bangladesh
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,937 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Johns Hopkins University, Bill and Melinda Gates Foundation, Canadian International Development Agency, Access Business Group
- Study start
- Jan 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 10 Aug 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 trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.
Detailed description
This is a randomized, double-masked, placebo-controlled, community trial of newborn vitamin A supplementation on mortality in the first six months of life. The trial is being implemented in 596 sectors (i.e. villages and/or smaller groupings), in two thanas comprising a population of ~580,000 in rural northern Bangladesh (Gaibandha/Rangpur area) and is nested within the JiVitA-1 maternal supplementation study. Women residing in the study area are already under 5-weekly pregnancy surveillance conducted by village-based field staff as part of the maternal supplementation trial. During their third trimester of pregnancy, women are visited by a study supervisor who explains the purpose and procedures of the study. After obtaining informed consent, women are interviewed for possible risk factors in the third trimester of pregnancy, including a 30-day history of morbidity, a 7-day dietary and alcohol intake and tobacco use questionnaire, a 7-day household chores questionnaire, and maternal anthropometry (mid upper arm circumference measurement). Upon birth, household members contact the village-based field staff who immediately administers the vitamin A or placebo to the infant, according to sector assignment. After supplementation, newborns are measured for weight, length and mid-upper arm, head and chest circumference, and then followed weekly for vital status for three months, and again at six months of age. A child death initiates the process of death verification and cause of death determination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)Supplement containing soybean oil with a small amount of vitamin E as an antioxidant |
| Vitamin A | Active comparator | Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)15,000 ug retinol equivalents (50,000 International Units) |
Who may qualify
- Ages
- 1 minute to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 supplementation (15,000 ug retinol equivalents or 50,000 IU)Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo | Dietary supplement | Placebo, Vitamin A |
Primary outcome
24-week infant mortality rate
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 3 Oct 2022.
- Derived from this study: PubMed 28490513Ali H, Hamadani J, Mehra S, Tofail F, Hasan MI, Shaikh S, Shamim AA, Wu LS, West KP Jr, Christian P. Effect of maternal antenatal and newborn supplementation with vitamin A on cognitive development of school-aged children in rural Bangladesh: a follow-up of a placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Jul;106(1):77-87. doi: 10.3945/ajcn.116.134478. Epub 2017 May 10.
- Derived from this study: PubMed 21832026Coles CL, Labrique A, Saha SK, Ali H, Al-Emran H, Rashid M, Christian P, West KP Jr, Klemm R. Newborn vitamin A supplementation does not affect nasopharyngeal carriage of Streptococcus pneumoniae in Bangladeshi infants at age 3 months. J Nutr. 2011 Oct;141(10):1907-11. doi: 10.3945/jn.111.141622. Epub 2011 Aug 10.
- Micronutrient research at the Center for Human Nutrition at Johns Hopkins Bloomberg School of Public Health)Link provided by the sponsor.
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.
Rolf DW Klemm, Dr PH principal investigator
Johns Hopkins University
Keith P West, Jr., Dr. P.H. study director
Johns Hopkins Bloomberg School of Public Health
Parul Christian, Dr. P.H. study director
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU) in people with Mortality Through Six Months of Age and Vitamin A Deficiency, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
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 3 Oct 2022. 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 Bangladesh. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
24-week infant mortality rate. 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 NCT00128557, 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 3 Oct 2022.