Trials / Completed
CompletedNCT05073978
B-vitamin Levels and Adverse Pregnancy Outcomes
The Association Between Niacin Deficiency and Birth Defects: a Case-control Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 7,500 (actual)
- Sponsor
- Westlake University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Birth Defect
- Pregnancy Loss
- Pregnancy Complications
- Pregnancy Induced Hypertension
- Recurrent Pregnancy Loss
- Health Problems in Pregnancy
- Gestational Diabetes
- Gestational Hypertension
- Preterm Birth
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | This is an observational study without any intervention |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2021-10-12
- Last updated
- 2023-06-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05073978. Inclusion in this directory is not an endorsement.