B-vitamin Levels and Adverse Pregnancy Outcomes

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05073978
• Other study ID #: 20210119SHJ001
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Birth Defect
• Congenital Abnormalities
• Diabetes, Gestational
• Fetal Death
• Gestational Diabetes
• Gestational Hypertension
• Health Problems in Pregnancy
• Hypertension
• Hypertension, Pregnancy-Induced
• Pregnancy Complications
• Pregnancy Induced Hypertension
• Pregnancy Loss
• Premature Birth
• Preterm Birth
• Recurrent Pregnancy Loss

Intervention

Other:
• No intervention
This is an observational study without any intervention

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Westlake University	Beijing Obstetrics and Gynecology Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fetal outcomes	Including intrauterine growth retardation,abortion, stillbirth, preterm birth, live birth	at delivery
Primary	fetal outcomes	Including birth defects	42 days after delivery
Primary	maternal outcomes	Including gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism	at delivery