B-vitamin Levels and Adverse Pregnancy Outcomes

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications; Preterm Birth; Gestational Diabetes; Pregnancy Loss; Recurrent Pregnancy Loss; Birth Defect; Gestational Hypertension; Pregnancy Induced Hypertension; Health Problems in Pregnancy
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 7500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Obstetrics and Gynecology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

all pregnant women recruited in the birth cohort of Beijing Obstetrics and Gynecology Hospital between 2020.12 to 2021.12

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; Case group with certain pregnancy outcome, e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc.	Other: No intervention; This is an observational study without any intervention
Control group; Control group without certain pregnancy outcome,e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc.	Other: No intervention; This is an observational study without any intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Westlake University
• Collaborators: Beijing Obstetrics and Gynecology Hospital
• Investigators: Principal Investigator: Hongjun Shi, PhD, Westlake University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy outcome; vitamin B
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Obstetric Labor Complications; Obstetric Labor, Premature; Death; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Congenital Abnormalities; Premature Birth; Abortion, Spontaneous; Pregnancy Complications; Diabetes, Gestational; Hypertension, Pregnancy-Induced; Fetal Death
• Other Study ID Numbers: 20210119SHJ001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No