Vitamin A DeficiencyPhase 3NCT00198822
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
A Phase 3 study testing Vitamin A or Beta-Carotene Supplements in people with Vitamin A Deficiency and Maternal Mortality, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in 2 countries.
Trial summary
The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency, Maternal Mortality, Infant Mortality
- What is being tested?
- Vitamin A or Beta-Carotene Supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59,666 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2001to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Married women of reproductive age
- First pregnancy during time period of trial
Who cannot join
- Premenarchial girls
- Married women with a previous pregnancy enrolled into the trial
- Previously married women who have moved into the study area
- Single women (never married, widowers)
- Women who are sterilized (or whose husbands are sterilized)
- Menopausal women
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Bangladesh2 sites
JiVitA Bangladesh Project
Rangpur, Rajshahi Division
JiVitA Project Office
Rangpur City, Rangpur District, 5400
United States1 site
Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
About this study
The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.
Read the detailed description
Maternal mortality and vitamin A deficiency coexist in rural South Asia. In Nepal, weekly supplementation with vitamin A or beta-carotene during the child-bearing years reduced all-cause maternal mortality and, in night blind women, also infant mortality. The present trial is testing the efficacy of the same supplements from ~9 weeks' gestation to 12 weeks postpartum. The planned sample size is 68,000 pregnancies. It is being conducted in 19 rural unions, covering an area of ~750 sq km with a population of ~580,000 in Gaibandha and Southern Rangpur Districts in Northern Bangladesh. The study area was mapped as 596 "sectors" (unit of randomization), each comprising 200-275 households; ~135,000 houses were numerically addressed and, at the outset, 103,000 women were listed. Women are visited at home every 5 weeks by 596 trained female staff to detect pregnancy by a combination of menstrual history and urine testing. Newly married women are prospectively enlisted for pregnancy surveillance. Following informed consent urine-positive (pregnant) women detected during surveillance are enrolled to receive weekly a capsule containing 7000 retinol equivalents of preformed vitamin A, 42 mg of beta-carotene or placebo. Vital events are recorded weekly through 3 months postpartum. Trained interviewers conduct maternal nutritional and health and household socioeconomic assessments in the 1st trimester. At 3 months postpartum, interviewers assess both mother and infant for health and nutritional status, including apparent birth defects that are later physician-confirmed. An additional home health assessment occurs at 6 months post partum, and vital status is recorded for mother and infant at one year postpartum. A ~3% subsample of enrolled pregnant women participate in a substudy involving enhanced clinical, anthropometric, biochemical, body compositional, morbidity and interview-based assessment protocols in the 1st, 2nd and 3rd trimesters, and at 3 months post-partum. Reported maternal and infant deaths are verified and causes ascertained during "verbal autopsy" interviews with family members of the deceased.
- Conditions
- Vitamin A Deficiency, Maternal Mortality, Infant Mortality
- Being tested
- Vitamin A or Beta-Carotene Supplements
- Keywords
- Maternal mortality, Infant mortality, Vitamin A, Beta-carotene, Micronutrients, Bangladesh, Neonatal mortality
- Medical subject headings
- Vitamin A Deficiency, Maternal Death, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A or Beta-Carotene SupplementsDietary supplement
weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Weekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy Receives: Dietary Supplement: Vitamin A or Beta-Carotene Supplements |
| 2 | Experimental | Weekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy Receives: Dietary Supplement: Vitamin A or Beta-Carotene Supplements |
| 3 | Placebo comparator | Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy Receives: Dietary Supplement: Vitamin A or Beta-Carotene Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause, Pregnancy-related Mortality
Mortality evaluated on intent-to-treat basis
Measured: Deaths during pregnancy through 12 weeks postpartum
Secondary outcomes (7)
All-cause 3-month Infant Mortality
Measured: Deaths through the 1st 12 weeks of life
Maternal Morbidity, Including Obstetric Complications
Measured: through the 1st 24 weeks following termination of pregnancy
Gestational Age at Birth
Measured: within 24 weeks after birth
Fetal Growth and Postnatal Infant Growth Through Three Months of Age
Measured: through the 1st 12 weeks after birth
Infant Morbidity Through 3 Months of Age
Measured: within 24 weeks after birth
Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)
Measured: Third trimester of pregnancy (about the 32nd week of gesatation)
Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)
Measured: Third trimester of pregnancy (about the 32nd week of gestation)
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 startAug 2001
- Primary completionJan 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59,666 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), Bill and Melinda Gates Foundation, Canadian International Development Agency, The Sight and Life Research Institute, Access Business Group
- Responsible party
- Principal investigator, Keith P. West, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Keith P West, Jr., Dr.P.H., Principal investigator, Johns Hopkins Bloomberg School of Public HealthParul Christian, Dr.P.H., Study director, Johns Hopkins Bloomberg School of Public HealthRolf DW Klemm, Dr.P.H., Study director, Johns Hopkins Bloomberg School of Public HealthMahbubur Rashid, MBBS, MSc, 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
- NCT00198822
- Sponsor's protocol ID
- GHS-A-00-03-00019-00
- Status last verified
- Mar 2012
- First submitted
- 12 Sep 2005
- Last updated
- 7 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
West KP Jr, Katz J, Khatry SK, LeClerq SC, Pradhan EK, Shrestha SR, Connor PB, Dali SM, Christian P, Pokhrel RP, Sommer A. Double blind, cluster randomised trial of low dose supplementation with vitamin A or beta carotene on mortality related to pregnancy in Nepal. The NNIPS-2 Study Group. BMJ. 1999 Feb 27;318(7183):570-5. doi: 10.1136/bmj.318.7183.570.
PubMed 10037634Katz J, West KP Jr, Khatry SK, Pradhan EK, LeClerq SC, Christian P, Wu LS, Adhikari RK, Shrestha SR, Sommer A. Maternal low-dose vitamin A or beta-carotene supplementation has no effect on fetal loss and early infant mortality: a randomized cluster trial in Nepal. Am J Clin Nutr. 2000 Jun;71(6):1570-6. doi: 10.1093/ajcn/71.6.1570.
PubMed 10837300Christian P, West KP Jr, Khatry SK, LeClerq SC, Kimbrough-Pradhan E, Katz J, Shrestha SR. Maternal night blindness increases risk of mortality in the first 6 months of life among infants in Nepal. J Nutr. 2001 May;131(5):1510-2. doi: 10.1093/jn/131.5.1510.
PubMed 11340108Christian P, West KP Jr, Khatry SK, Katz J, LeClerq SC, Kimbrough-Pradhan E, Dali SM, Shrestha SR. Vitamin A or beta-carotene supplementation reduces symptoms of illness in pregnant and lactating Nepali women. J Nutr. 2000 Nov;130(11):2675-82. doi: 10.1093/jn/130.11.2675.
PubMed 11053506Christian P, West KP Jr, Khatry SK, Kimbrough-Pradhan E, LeClerq SC, Katz J, Shrestha SR, Dali SM, Sommer A. Night blindness during pregnancy and subsequent mortality among women in Nepal: effects of vitamin A and beta-carotene supplementation. Am J Epidemiol. 2000 Sep 15;152(6):542-7. doi: 10.1093/aje/152.6.542.
PubMed 10997544West KP Jr. Extent of vitamin A deficiency among preschool children and women of reproductive age. J Nutr. 2002 Sep;132(9 Suppl):2857S-2866S. doi: 10.1093/jn/132.9.2857S.
PubMed 12221262West KP Jr, Christian P, Labrique AB, Rashid M, Shamim AA, Klemm RD, Massie AB, Mehra S, Schulze KJ, Ali H, Ullah B, Wu LS, Katz J, Banu H, Akhter HH, Sommer A. Effects of vitamin A or beta carotene supplementation on pregnancy-related mortality and infant mortality in rural Bangladesh: a cluster randomized trial. JAMA. 2011 May 18;305(19):1986-95. doi: 10.1001/jama.2011.656.
PubMed 21586714Labrique AB, Christian P, Klemm RD, Rashid M, Shamim AA, Massie A, Schulze K, Hackman A, West KP Jr. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods. Trials. 2011 Apr 21;12:102. doi: 10.1186/1745-6215-12-102.
PubMed 21510905Gunnsteinsson S, Labrique AB, West KP Jr, Christian P, Mehra S, Shamim AA, Rashid M, Katz J, Klemm RD. Constructing indices of rural living standards in Northwestern Bangladesh. J Health Popul Nutr. 2010 Oct;28(5):509-19. doi: 10.3329/jhpn.v28i5.6160.
PubMed 20941903Surkan PJ, Sakyi KS, Christian P, Mehra S, Labrique A, Ali H, Ullah B, Wu L, Klemm R, Rashid M, West KP Jr, Strobino DM. Risk of Depressive Symptoms Associated with Morbidity in Postpartum Women in Rural Bangladesh. Matern Child Health J. 2017 Oct;21(10):1890-1900. doi: 10.1007/s10995-017-2299-7.
PubMed 28766094Ali 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 28490513Sundaram ME, Ali H, Mehra S, Shamim AA, Ullah B, Rashid M, Shaikh S, Christian P, Klemm RD, West KP Jr, Labrique A. Early newborn ritual foods correlate with delayed breastfeeding initiation in rural Bangladesh. Int Breastfeed J. 2016 Dec 8;11:31. doi: 10.1186/s13006-016-0090-9. eCollection 2016.
PubMed 27980605Surkan PJ, Sakyi K, Strobino DM, Mehra S, Labrique A, Ali H, Ullah B, Wu L, Klemm R, Rashid M, West KP, Christian P. Depressive symptoms in mothers after perinatal and early infant loss in rural Bangladesh: a population-based study. Ann Epidemiol. 2016 Jul;26(7):467-473. doi: 10.1016/j.annepidem.2016.06.001. Epub 2016 Jun 8.
PubMed 27449568Shamim AA, Schulze K, Merrill RD, Kabir A, Christian P, Shaikh S, Wu L, Ali H, Labrique AB, Mehra S, Klemm RD, Rashid M, Sungpuag P, Udomkesmalee E, West KP Jr. First-trimester plasma tocopherols are associated with risk of miscarriage in rural Bangladesh. Am J Clin Nutr. 2015 Feb;101(2):294-301. doi: 10.3945/ajcn.114.094920. Epub 2014 Nov 26.
PubMed 25646326Christian P, Klemm R, Shamim AA, Ali H, Rashid M, Shaikh S, Wu L, Mehra S, Labrique A, Katz J, West KP Jr. Effects of vitamin A and beta-carotene supplementation on birth size and length of gestation in rural Bangladesh: a cluster-randomized trial. Am J Clin Nutr. 2013 Jan;97(1):188-94. doi: 10.3945/ajcn.112.042275. Epub 2012 Nov 14.
PubMed 23151532
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
- ClinicalTrials.gov ID
- NCT00198822
- Acronym / sponsor ID
- GHS-A-00-03-00019-00
- Conditions
- Vitamin A Deficiency, Maternal Mortality, Infant Mortality
- Keywords
- Maternal mortality, Infant mortality, Vitamin A, Beta-carotene, Micronutrients, Bangladesh, Neonatal mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59,666 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Bill and Melinda Gates Foundation, Canadian International Development Agency, The Sight and Life Research Institute, Access Business Group
- Study start
- Aug 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 12 Oct 2011
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 to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.
Detailed description
Maternal mortality and vitamin A deficiency coexist in rural South Asia. In Nepal, weekly supplementation with vitamin A or beta-carotene during the child-bearing years reduced all-cause maternal mortality and, in night blind women, also infant mortality. The present trial is testing the efficacy of the same supplements from ~9 weeks' gestation to 12 weeks postpartum. The planned sample size is 68,000 pregnancies. It is being conducted in 19 rural unions, covering an area of ~750 sq km with a population of ~580,000 in Gaibandha and Southern Rangpur Districts in Northern Bangladesh. The study area was mapped as 596 "sectors" (unit of randomization), each comprising 200-275 households; ~135,000 houses were numerically addressed and, at the outset, 103,000 women were listed. Women are visited at home every 5 weeks by 596 trained female staff to detect pregnancy by a combination of menstrual history and urine testing. Newly married women are prospectively enlisted for pregnancy surveillance. Following informed consent urine-positive (pregnant) women detected during surveillance are enrolled to receive weekly a capsule containing 7000 retinol equivalents of preformed vitamin A, 42 mg of beta-carotene or placebo. Vital events are recorded weekly through 3 months postpartum. Trained interviewers conduct maternal nutritional and health and household socioeconomic assessments in the 1st trimester. At 3 months postpartum, interviewers assess both mother and infant for health and nutritional status, including apparent birth defects that are later physician-confirmed. An additional home health assessment occurs at 6 months post partum, and vital status is recorded for mother and infant at one year postpartum. A ~3% subsample of enrolled pregnant women participate in a substudy involving enhanced clinical, anthropometric, biochemical, body compositional, morbidity and interview-based assessment protocols in the 1st, 2nd and 3rd trimesters, and at 3 months post-partum. Reported maternal and infant deaths are verified and causes ascertained during "verbal autopsy" interviews with family members of the deceased.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Vitamin A or Beta-Carotene SupplementsWeekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy |
| 2 | Experimental | Dietary Supplement: Vitamin A or Beta-Carotene SupplementsWeekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy |
| 3 | Placebo comparator | Dietary Supplement: Vitamin A or Beta-Carotene SupplementsWeekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Married women of reproductive age
- First pregnancy during time period of trial
Key exclusion criteria (6 listed)
- Premenarchial girls
- Married women with a previous pregnancy enrolled into the trial
- Previously married women who have moved into the study area
- Single women (never married, widowers)
- Women who are sterilized (or whose husbands are sterilized)
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 or Beta-Carotene Supplementsweekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy | Dietary supplement | 1, 2, 3 |
Primary outcome
All-cause, Pregnancy-related Mortality
Time frame: Deaths during pregnancy through 12 weeks postpartum
Mortality evaluated on intent-to-treat basis
7 secondary outcomes
All-cause 3-month Infant Mortality
Time frame: Deaths through the 1st 12 weeks of life
Maternal Morbidity, Including Obstetric Complications
Time frame: through the 1st 24 weeks following termination of pregnancy
Gestational Age at Birth
Time frame: within 24 weeks after birth
Fetal Growth and Postnatal Infant Growth Through Three Months of Age
Time frame: through the 1st 12 weeks after birth
Infant Morbidity Through 3 Months of Age
Time frame: within 24 weeks after birth
Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)
Time frame: Third trimester of pregnancy (about the 32nd week of gesatation)
Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)
Time frame: Third trimester of pregnancy (about the 32nd week of gestation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10037634West KP Jr, Katz J, Khatry SK, LeClerq SC, Pradhan EK, Shrestha SR, Connor PB, Dali SM, Christian P, Pokhrel RP, Sommer A. Double blind, cluster randomised trial of low dose supplementation with vitamin A or beta carotene on mortality related to pregnancy in Nepal. The NNIPS-2 Study Group. BMJ. 1999 Feb 27;318(7183):570-5. doi: 10.1136/bmj.318.7183.570.
- Background: PubMed 10837300Katz J, West KP Jr, Khatry SK, Pradhan EK, LeClerq SC, Christian P, Wu LS, Adhikari RK, Shrestha SR, Sommer A. Maternal low-dose vitamin A or beta-carotene supplementation has no effect on fetal loss and early infant mortality: a randomized cluster trial in Nepal. Am J Clin Nutr. 2000 Jun;71(6):1570-6. doi: 10.1093/ajcn/71.6.1570.
- Background: PubMed 11340108Christian P, West KP Jr, Khatry SK, LeClerq SC, Kimbrough-Pradhan E, Katz J, Shrestha SR. Maternal night blindness increases risk of mortality in the first 6 months of life among infants in Nepal. J Nutr. 2001 May;131(5):1510-2. doi: 10.1093/jn/131.5.1510.
- Background: PubMed 11053506Christian P, West KP Jr, Khatry SK, Katz J, LeClerq SC, Kimbrough-Pradhan E, Dali SM, Shrestha SR. Vitamin A or beta-carotene supplementation reduces symptoms of illness in pregnant and lactating Nepali women. J Nutr. 2000 Nov;130(11):2675-82. doi: 10.1093/jn/130.11.2675.
- Background: PubMed 10997544Christian P, West KP Jr, Khatry SK, Kimbrough-Pradhan E, LeClerq SC, Katz J, Shrestha SR, Dali SM, Sommer A. Night blindness during pregnancy and subsequent mortality among women in Nepal: effects of vitamin A and beta-carotene supplementation. Am J Epidemiol. 2000 Sep 15;152(6):542-7. doi: 10.1093/aje/152.6.542.
- Background: PubMed 12221262West KP Jr. Extent of vitamin A deficiency among preschool children and women of reproductive age. J Nutr. 2002 Sep;132(9 Suppl):2857S-2866S. doi: 10.1093/jn/132.9.2857S.
- Results publication: PubMed 21586714West KP Jr, Christian P, Labrique AB, Rashid M, Shamim AA, Klemm RD, Massie AB, Mehra S, Schulze KJ, Ali H, Ullah B, Wu LS, Katz J, Banu H, Akhter HH, Sommer A. Effects of vitamin A or beta carotene supplementation on pregnancy-related mortality and infant mortality in rural Bangladesh: a cluster randomized trial. JAMA. 2011 May 18;305(19):1986-95. doi: 10.1001/jama.2011.656.
- Results publication: PubMed 21510905Labrique AB, Christian P, Klemm RD, Rashid M, Shamim AA, Massie A, Schulze K, Hackman A, West KP Jr. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods. Trials. 2011 Apr 21;12:102. doi: 10.1186/1745-6215-12-102.
- Results publication: PubMed 20941903Gunnsteinsson S, Labrique AB, West KP Jr, Christian P, Mehra S, Shamim AA, Rashid M, Katz J, Klemm RD. Constructing indices of rural living standards in Northwestern Bangladesh. J Health Popul Nutr. 2010 Oct;28(5):509-19. doi: 10.3329/jhpn.v28i5.6160.
- Derived from this study: PubMed 28766094Surkan PJ, Sakyi KS, Christian P, Mehra S, Labrique A, Ali H, Ullah B, Wu L, Klemm R, Rashid M, West KP Jr, Strobino DM. Risk of Depressive Symptoms Associated with Morbidity in Postpartum Women in Rural Bangladesh. Matern Child Health J. 2017 Oct;21(10):1890-1900. doi: 10.1007/s10995-017-2299-7.
- 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 27980605Sundaram ME, Ali H, Mehra S, Shamim AA, Ullah B, Rashid M, Shaikh S, Christian P, Klemm RD, West KP Jr, Labrique A. Early newborn ritual foods correlate with delayed breastfeeding initiation in rural Bangladesh. Int Breastfeed J. 2016 Dec 8;11:31. doi: 10.1186/s13006-016-0090-9. eCollection 2016.
- Micronutrient research at the Center for Human Nutrition at Johns Hopkins Bloomberg School of Public HealthLink provided by the sponsor.
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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.
Keith P West, Jr., Dr.P.H. principal investigator
Johns Hopkins Bloomberg School of Public Health
Parul Christian, Dr.P.H. study director
Johns Hopkins Bloomberg School of Public Health
Rolf DW Klemm, Dr.P.H. study director
Johns Hopkins Bloomberg School of Public Health
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin A or Beta-Carotene Supplements in people with Vitamin A Deficiency and Maternal Mortality, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. 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 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bangladesh, 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. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
All-cause, Pregnancy-related Mortality (time frame: Deaths during pregnancy through 12 weeks postpartum). 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 NCT00198822, which also lists 17 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 7 Mar 2012.