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B-vitamin Levels and Adverse Pregnancy Outcomes

The Association Between Niacin Deficiency and Birth Defects: a Case-control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05073978
Enrollment
7500
Registered
2021-10-12
Start date
2020-12-01
Completion date
2022-12-31
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Defect, Gestational Diabetes, Gestational Hypertension, Health Problems in Pregnancy, Pregnancy Complications, Pregnancy Induced Hypertension, Pregnancy Loss, Preterm Birth, Recurrent Pregnancy Loss

Keywords

vitamin B, pregnancy outcome

Brief 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

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.

Interventions

OTHERNo intervention

This is an observational study without any intervention

Sponsors

Beijing Obstetrics and Gynecology Hospital
CollaboratorOTHER
Westlake University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.

Design outcomes

Primary

MeasureTime frameDescription
fetal outcomesat deliveryIncluding intrauterine growth retardation,abortion, stillbirth, preterm birth, live birth
maternal outcomesat deliveryIncluding gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026