Skip to main content
OpenTrials
Completed

NCT Number: NCT05073978

B-vitamin Levels and Adverse Pregnancy Outcomes

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is an observational study without any intervention

Primary outcomes

  1. fetal outcomes

    Time frame: at delivery

    Including intrauterine growth retardation,abortion, stillbirth, preterm birth, live birth

  2. fetal outcomes

    Time frame: 42 days after delivery

    Including birth defects

  3. maternal outcomes

    Time frame: at delivery

    Including gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Collaborators

  • Beijing Obstetrics and Gynecology Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2021
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.