Birth DefectNCT05073978
B-vitamin Levels and Adverse Pregnancy Outcomes
An observational study of Birth Defect and Pregnancy Loss, run by Westlake University at 1 site in China.
Trial summary
This prospective nested case-control study aims to examine the effects of blood vitamin B levels in first-trimester pregnant women on the pregnancy outcomes Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Defect, Pregnancy Loss, Pregnancy Complications
- How many people
- 7,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2022
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: all pregnant women recruited in the birth cohort of Beijing Obstetrics and Gynecology Hospital between 2020.12 to 2021.12
Who may be able to join
- Pregnant women with 6-13(+6 days) gestational weeks
- Resided in Beijing in the past year
- Pregnant women who intend to have antenatal examinations and delivery at Beijing Obstetrics and Gynecology Hospital
- Pregnant women who are willing to participate in this study with informed consent
Who cannot join
- Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, 100020
About this study
Official title: The Association Between Niacin Deficiency and Birth Defects: a Case-control Study
This prospective nested case-control study aims to examine the effects of blood vitamin B levels in first-trimester pregnant women on the pregnancy outcomes
Read the detailed description
Folate deficiency can cause severe adverse pregnancy outcomes, such as neural tube defects. Effective folate functioning requires essential metabolic interactions with other B vitamins including vitamin B2, vitamin B3, vitamin B6, and vitamin B12, which can also influence pregnancy outcomes independently. For example, animal and family studies have identified that niacin (B3) deficiency can lead to congenital malformations. However, how folate and related B-vitamin levels interact with each other while affecting various pregnancy outcomes including abortion, birth defects, pregnancy complications, etc. is unclear. Besides, folate levels in previous studies were mostly measured in plasma which are easily influenced by dietary factors, instead of red blood cell folate which can reflect the long-term status. Moreover, the difference in the risk of neural tube defects across a range of maternal red blood cell folate concentrations has been largely ignored. Using data of pregnant women recruited at Beijing Obstetrics and Gynecology Hospital from December 2020 to December 2021, this case-control study aims to examine the association of folate and related B-vitamin levels in first-trimester blood samples (plasma and red blood cell) with pregnancy outcomes, particularly the association between niacin deficiency and birth defects.
- Conditions
- Birth Defect, Pregnancy Loss, Pregnancy Complications, Pregnancy Induced Hypertension, Recurrent Pregnancy Loss, Health Problems in Pregnancy
- Being tested
- No intervention
- Keywords
- vitamin B, pregnancy outcome
- Medical subject headings
- Congenital Abnormalities, Pregnancy Complications, Hypertension, Pregnancy-Induced, Diabetes, Gestational, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study without any intervention
| Study group | Role | What they receive |
|---|---|---|
| Case group | Case group with certain pregnancy outcome, e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc. Receives: Other: No intervention | |
| Control group | Control group without certain pregnancy outcome,e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal outcomes
Including intrauterine growth retardation,abortion, stillbirth, preterm birth, live birth
Measured: at delivery
fetal outcomes
Including birth defects
Measured: 42 days after delivery
maternal outcomes
Including gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth DefectStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital
- Responsible party
- Sponsor
- Investigators
- Hongjun Shi, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073978
- Sponsor's protocol ID
- 20210119SHJ001
- Status last verified
- May 2023
- First submitted
- 22 Sep 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Niacin Deficiency and Birth Defects: a Case-control Study
- ClinicalTrials.gov ID
- NCT05073978
- Acronym / sponsor ID
- 20210119SHJ001
- Conditions
- Birth Defect, Pregnancy Loss, Pregnancy Complications, Pregnancy Induced Hypertension, Recurrent Pregnancy Loss, Health Problems in Pregnancy
- Keywords
- vitamin B, pregnancy outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- 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.
This prospective nested case-control study aims to examine the effects of blood vitamin B levels in first-trimester pregnant women on the pregnancy outcomes
Detailed description
Folate deficiency can cause severe adverse pregnancy outcomes, such as neural tube defects. Effective folate functioning requires essential metabolic interactions with other B vitamins including vitamin B2, vitamin B3, vitamin B6, and vitamin B12, which can also influence pregnancy outcomes independently. For example, animal and family studies have identified that niacin (B3) deficiency can lead to congenital malformations. However, how folate and related B-vitamin levels interact with each other while affecting various pregnancy outcomes including abortion, birth defects, pregnancy complications, etc. is unclear. Besides, folate levels in previous studies were mostly measured in plasma which are easily influenced by dietary factors, instead of red blood cell folate which can reflect the long-term status. Moreover, the difference in the risk of neural tube defects across a range of maternal red blood cell folate concentrations has been largely ignored. Using data of pregnant women recruited at Beijing Obstetrics and Gynecology Hospital from December 2020 to December 2021, this case-control study aims to examine the association of folate and related B-vitamin levels in first-trimester blood samples (plasma and red blood cell) with pregnancy outcomes, particularly the association between niacin deficiency and birth defects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: No interventionCase group with certain pregnancy outcome, e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc. |
| Control group | – | Other: No interventionControl group without certain pregnancy outcome,e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all pregnant women recruited in the birth cohort of Beijing Obstetrics and Gynecology Hospital between 2020.12 to 2021.12
Key inclusion criteria (4 listed)
- Pregnant women with 6-13(+6 days) gestational weeks
- Resided in Beijing in the past year
- Pregnant women who intend to have antenatal examinations and delivery at Beijing Obstetrics and Gynecology Hospital
- Pregnant women who are willing to participate in this study with informed consent
Key exclusion criteria (1 listed)
- Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
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 |
|---|---|---|
| No interventionThis is an observational study without any intervention | Other | Case group, Control group |
Primary outcome
fetal outcomes
Time frame: at delivery
Including intrauterine growth retardation,abortion, stillbirth, preterm birth, live birth
fetal outcomes
Time frame: 42 days after delivery
Including birth defects
maternal outcomes
Time frame: at delivery
Including gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism
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 1 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Hongjun Shi, PhD principal investigator
Westlake University
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 Birth Defect and Pregnancy Loss, run by Westlake University at 1 site in China.
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 4 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 1 Jun 2023. 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 China. 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?
fetal outcomes (time frame: at 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?
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 1 Jun 2023.