Infant MortalityPhase 3JiVitA-3NCT00860470
Antenatal Micronutrient Supplementation and Infant Survival
A Phase 3 study testing Iron (27 mg) - folic acid (600 ug) and Multiple micronutrient in people with Infant Mortality and Preterm Birth, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in 2 countries.
Trial summary
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant Mortality, Preterm Birth, Low Birth Weight
- What is being tested?
- Iron (27 mg) - folic acid (600 ug) and Multiple micronutrient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44,567 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2008to Sep 2012
- 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 12 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant and consents to participate
Who cannot join
- Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.
Read the detailed description
Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a ~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality, Perinatal Mortality
- Being tested
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Keywords
- micronutrients, deficiency, pregnancy, birth outcomes, infant mortality, neonatal mortality, malnutrition, antenatal
- Medical subject headings
- Infant Death, Premature Birth, Perinatal Death, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron (27 mg) - folic acid (600 ug)Dietary supplement
Also called iron-folate
Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
Multiple micronutrientDietary supplement
Also called one-a-day multivitamin, antenatal micronutrient
Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Iron (27 mg) and folic acid (600 ug) Receives: Dietary Supplement: Iron (27 mg) - folic acid (600 ug) |
| 2 | Experimental | Multiple micronutrient Receives: Dietary Supplement: Multiple micronutrient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Mortality Through 6 mo of Age
Infant Mortality to Age 6 months (180 days from birth)
Measured: 6-months post-birth
Secondary outcomes (9)
Neonatal Mortality
Neonatal Mortality (28 days of life)
Measured: 1 month post-birth
Post-neonatal Mortality
Risk of Post-neonatal Mortality (29th -180th day of life)
Measured: 1-6 months post-birth
Still Birth Rates
Stillbirth (born >=24 weeks without breathing, crying, or moving limbs).
Measured: 24 weeks gestation to delivery
Preterm Birth
Being born before 37 weeks of gestation
Measured: Up to 37 weeks of gestation
Extremely Pre-term
Birth before 28 weeks gestation
Measured: Up to 28 weeks of gestation
Very Pre-term
Birth between 28 and 32 weeks of gestation
Measured: Between 27 and 33 weeks of gestation
Moderate to Late Preterm
Birth between 32 and 37 weeks gestation
Measured: Between 31 and 38 weeks of gestation
Low Birth Weight
Birth weight below 2500g
Measured: Measured at delivery/birth
Small for Gestation Age
Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).
Measured: At delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionSep 2012
- Study completionSep 2012
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 (24)Papers the sponsor has linked to this study.
- Other trials for Infant MortalityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44,567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, United States Agency for International Development (USAID), Mahidol University, Johns Hopkins University, Beximco Pharmaceuticals Ltd., dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Keith P West, Jr., Principal investigator, Johns Hopkins Bloomberg School of Public HealthParul Christian, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860470
- Sponsor's protocol ID
- JHU_IRB 570
- Acronym
- JiVitA-3
- Status last verified
- Oct 2022
- First submitted
- 11 Mar 2009
- Last updated
- 19 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Christian P, Khatry SK, Katz J, Pradhan EK, LeClerq SC, Shrestha SR, Adhikari RK, Sommer A, West KP Jr. Effects of alternative maternal micronutrient supplements on low birth weight in rural Nepal: double blind randomised community trial. BMJ. 2003 Mar 15;326(7389):571. doi: 10.1136/bmj.326.7389.571.
PubMed 12637400Christian P. Micronutrients and reproductive health issues: an international perspective. J Nutr. 2003 Jun;133(6):1969S-1973S. doi: 10.1093/jn/133.6.1969S.
PubMed 12771347Christian P, Shrestha J, LeClerq SC, Khatry SK, Jiang T, Wagner T, Katz J, West KP Jr. Supplementation with micronutrients in addition to iron and folic acid does not further improve the hematologic status of pregnant women in rural Nepal. J Nutr. 2003 Nov;133(11):3492-8. doi: 10.1093/jn/133.11.3492.
PubMed 14608063Christian P, West KP, Khatry SK, Leclerq SC, Pradhan EK, Katz J, Shrestha SR, Sommer A. Effects of maternal micronutrient supplementation on fetal loss and infant mortality: a cluster-randomized trial in Nepal. Am J Clin Nutr. 2003 Dec;78(6):1194-202. doi: 10.1093/ajcn/78.6.1194.
PubMed 14668283Katz J, West KP Jr, Khatry SK, Christian P, LeClerq SC, Pradhan EK, Shrestha SR. Risk factors for early infant mortality in Sarlahi district, Nepal. Bull World Health Organ. 2003;81(10):717-25. Epub 2003 Nov 25.
PubMed 14758431Jiang T, Christian P, Khatry SK, Wu L, West KP Jr. Micronutrient deficiencies in early pregnancy are common, concurrent, and vary by season among rural Nepali pregnant women. J Nutr. 2005 May;135(5):1106-12. doi: 10.1093/jn/135.5.1106.
PubMed 15867289Christian P, Osrin D, Manandhar DS, Khatry SK, de L Costello AM, West KP Jr. Antenatal micronutrient supplements in Nepal. Lancet. 2005 Aug 27-Sep 2;366(9487):711-2. doi: 10.1016/S0140-6736(05)67166-8. No abstract available.
PubMed 16125578Christian P, Jiang T, Khatry SK, LeClerq SC, Shrestha SR, West KP Jr. Antenatal supplementation with micronutrients and biochemical indicators of status and subclinical infection in rural Nepal. Am J Clin Nutr. 2006 Apr;83(4):788-94. doi: 10.1093/ajcn/83.4.788.
PubMed 16600929Katz J, Christian P, Dominici F, Zeger SL. Treatment effects of maternal micronutrient supplementation vary by percentiles of the birth weight distribution in rural Nepal. J Nutr. 2006 May;136(5):1389-94. doi: 10.1093/jn/136.5.1389.
PubMed 16614435West KP Jr, Christian P. Antenatal micronutrients in undernourished people. Lancet. 2008 Feb 9;371(9611):452-4. doi: 10.1016/S0140-6736(08)60214-7. No abstract available.
PubMed 18262025Christian P, Darmstadt GL, Wu L, Khatry SK, Leclerq SC, Katz J, West KP Jr, Adhikari RK. The effect of maternal micronutrient supplementation on early neonatal morbidity in rural Nepal: a randomised, controlled, community trial. Arch Dis Child. 2008 Aug;93(8):660-4. doi: 10.1136/adc.2006.114009.
PubMed 18644934Shankar AH, Genton B, Baisor M, Paino J, Tamja S, Adiguma T, Wu L, Rare L, Bannon D, Tielsch JM, West KP Jr, Alpers MP. The influence of zinc supplementation on morbidity due to Plasmodium falciparum: a randomized trial in preschool children in Papua New Guinea. Am J Trop Med Hyg. 2000 Jun;62(6):663-9. doi: 10.4269/ajtmh.2000.62.663.
PubMed 11304051de Boer M, Thorne-Lyman AL, Shamim AA, Wu LS, Shaikh S, Ali H, West KP, Christian P. Dietary diversity as a modifier of the effect of supplementation with multiple micronutrients during pregnancy on low birth weight in a randomized controlled trial in Bangladesh. Am J Clin Nutr. 2025 Sep;122(3):762-769. doi: 10.1016/j.ajcnut.2025.07.007. Epub 2025 Jul 12.
PubMed 40653272Finkelstein JL, Cuthbert A, Weeks J, Venkatramanan S, Larvie DY, De-Regil LM, Garcia-Casal MN. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD004736. doi: 10.1002/14651858.CD004736.pub6.
PubMed 39145520Kim H, Bedsaul-Fryer JR, Schulze KJ, Sincerbeaux G, Baker S, Rebholz CM, Wu LS, Gogain J, Cuddeback L, Yager JD, De Luca LM, Siddiqua TJ, West KP Jr. An Early Gestation Plasma Inflammasome in Rural Bangladeshi Women. Biomolecules. 2024 Jun 21;14(7):736. doi: 10.3390/biom14070736.
PubMed 39062451
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
- ClinicalTrials.gov ID
- NCT00860470
- Acronym / sponsor ID
- JiVitA-3 / JHU_IRB 570
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality, Perinatal Mortality
- Keywords
- micronutrients, deficiency, pregnancy, birth outcomes, infant mortality, neonatal mortality, malnutrition, antenatal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44,567 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, United States Agency for International Development (USAID), Mahidol University, Johns Hopkins University, Beximco Pharmaceuticals Ltd., dsm-firmenich Switzerland AG
- Study start
- Jan 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Posted 27 May 2015
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 community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.
Detailed description
Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a ~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Iron (27 mg) - folic acid (600 ug)Iron (27 mg) and folic acid (600 ug) |
| 2 | Experimental | Dietary Supplement: Multiple micronutrientMultiple micronutrient |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant and consents to participate
Key exclusion criteria (1 listed)
- Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing
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 |
|---|---|---|
| Iron (27 mg) - folic acid (600 ug)Also: iron-folateSupplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum. | Dietary supplement | 1 |
| Multiple micronutrientAlso: one-a-day multivitamin, antenatal micronutrientContaining 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum. | Dietary supplement | 2 |
Primary outcome
Infant Mortality Through 6 mo of Age
Time frame: 6-months post-birth
Infant Mortality to Age 6 months (180 days from birth)
9 secondary outcomes
Neonatal Mortality
Time frame: 1 month post-birth
Post-neonatal Mortality
Time frame: 1-6 months post-birth
Still Birth Rates
Time frame: 24 weeks gestation to delivery
Preterm Birth
Time frame: Up to 37 weeks of gestation
Extremely Pre-term
Time frame: Up to 28 weeks of gestation
Very Pre-term
Time frame: Between 27 and 33 weeks of gestation
Moderate to Late Preterm
Time frame: Between 31 and 38 weeks of gestation
Low Birth Weight
Time frame: Measured at delivery/birth
Small for Gestation Age
Time frame: At delivery/birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12637400Christian P, Khatry SK, Katz J, Pradhan EK, LeClerq SC, Shrestha SR, Adhikari RK, Sommer A, West KP Jr. Effects of alternative maternal micronutrient supplements on low birth weight in rural Nepal: double blind randomised community trial. BMJ. 2003 Mar 15;326(7389):571. doi: 10.1136/bmj.326.7389.571.
- Background: PubMed 12771347Christian P. Micronutrients and reproductive health issues: an international perspective. J Nutr. 2003 Jun;133(6):1969S-1973S. doi: 10.1093/jn/133.6.1969S.
- Background: PubMed 14608063Christian P, Shrestha J, LeClerq SC, Khatry SK, Jiang T, Wagner T, Katz J, West KP Jr. Supplementation with micronutrients in addition to iron and folic acid does not further improve the hematologic status of pregnant women in rural Nepal. J Nutr. 2003 Nov;133(11):3492-8. doi: 10.1093/jn/133.11.3492.
- Background: PubMed 14668283Christian P, West KP, Khatry SK, Leclerq SC, Pradhan EK, Katz J, Shrestha SR, Sommer A. Effects of maternal micronutrient supplementation on fetal loss and infant mortality: a cluster-randomized trial in Nepal. Am J Clin Nutr. 2003 Dec;78(6):1194-202. doi: 10.1093/ajcn/78.6.1194.
- Background: PubMed 14758431Katz J, West KP Jr, Khatry SK, Christian P, LeClerq SC, Pradhan EK, Shrestha SR. Risk factors for early infant mortality in Sarlahi district, Nepal. Bull World Health Organ. 2003;81(10):717-25. Epub 2003 Nov 25.
- Background: PubMed 15867289Jiang T, Christian P, Khatry SK, Wu L, West KP Jr. Micronutrient deficiencies in early pregnancy are common, concurrent, and vary by season among rural Nepali pregnant women. J Nutr. 2005 May;135(5):1106-12. doi: 10.1093/jn/135.5.1106.
- Background: PubMed 16125578Christian P, Osrin D, Manandhar DS, Khatry SK, de L Costello AM, West KP Jr. Antenatal micronutrient supplements in Nepal. Lancet. 2005 Aug 27-Sep 2;366(9487):711-2. doi: 10.1016/S0140-6736(05)67166-8. No abstract available.
- Background: PubMed 16600929Christian P, Jiang T, Khatry SK, LeClerq SC, Shrestha SR, West KP Jr. Antenatal supplementation with micronutrients and biochemical indicators of status and subclinical infection in rural Nepal. Am J Clin Nutr. 2006 Apr;83(4):788-94. doi: 10.1093/ajcn/83.4.788.
- Background: PubMed 16614435Katz J, Christian P, Dominici F, Zeger SL. Treatment effects of maternal micronutrient supplementation vary by percentiles of the birth weight distribution in rural Nepal. J Nutr. 2006 May;136(5):1389-94. doi: 10.1093/jn/136.5.1389.
- Background: PubMed 18262025West KP Jr, Christian P. Antenatal micronutrients in undernourished people. Lancet. 2008 Feb 9;371(9611):452-4. doi: 10.1016/S0140-6736(08)60214-7. No abstract available.
- Background: PubMed 18644934Christian P, Darmstadt GL, Wu L, Khatry SK, Leclerq SC, Katz J, West KP Jr, Adhikari RK. The effect of maternal micronutrient supplementation on early neonatal morbidity in rural Nepal: a randomised, controlled, community trial. Arch Dis Child. 2008 Aug;93(8):660-4. doi: 10.1136/adc.2006.114009.
- Background: PubMed 11304051Shankar AH, Genton B, Baisor M, Paino J, Tamja S, Adiguma T, Wu L, Rare L, Bannon D, Tielsch JM, West KP Jr, Alpers MP. The influence of zinc supplementation on morbidity due to Plasmodium falciparum: a randomized trial in preschool children in Papua New Guinea. Am J Trop Med Hyg. 2000 Jun;62(6):663-9. doi: 10.4269/ajtmh.2000.62.663.
- Basic description of the JiVitA project, location and individualsLink 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. principal investigator
Johns Hopkins Bloomberg School of Public Health
Parul Christian principal investigator
Johns Hopkins Bloomberg School of Public Health
2 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 Iron (27 mg) - folic acid (600 ug) and Multiple micronutrient in people with Infant Mortality and Preterm Birth, run by Johns Hopkins Bloomberg School of Public Health at 2 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 1 inclusion and 1 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 19 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 2 sites in United States, 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. 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 27 May 2015). 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?
Infant Mortality Through 6 mo of Age (time frame: 6-months post-birth). 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 NCT00860470, which also lists 24 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 19 Oct 2022.