Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04064931 |
Other study ID # |
yuqi2019 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 1, 2019 |
Est. completion date |
November 2022 |
Study information
Verified date |
March 2021 |
Source |
Peking Union Medical College Hospital |
Contact |
Qi Yu, Professor |
Phone |
18612671865 |
Email |
yuqi2008001[@]sina.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The study plans to recruit patients with recurrent miscarriage and detect their niacin,
thiamine, vitamin A, vitamin B6, vitamin B12, vitamin D levels in plasma, evaluating if some
lack exists.
Description:
Dr. Shi Hongjun from West Lake University has confirmed in a mouse model that a decrease in
maternal niacin levels caused by a low niacin diet can lead to stillbirth(HJ Shi, et al.
2017). Due to the lack of a recognized clinical niacin test, it is unclear whether niacin
deficiency is associated with abortion. However, some studies have showed: 1. Nearly
one-third of pregnant women present low niacin level during the first trimester of pregnancy;
2. Insufficient parent niacin intake is positively correlated with the incidence of
congenital heart disease; 3. Vitamin B6 affects niacin metabolism, while maternal B6
deficiency is significantly associated with early abortion. Based on this, the investigators
predict that (1) a certain proportion of recurrent abortion women's niacin levels are lower
than the normal range of women's normal; (2) supplementation of niacin can reduce the risk of
repeated abortion.
There are many methods for detecting niacin, but so far with no reports for large population.
Dr. Shi Hongjun from West Lake University used the most sensitive QTRAP 6500+ liquid
chromatography tandem mass spectrometer to accurately quantify the concentration of NAD,
nicotinamide, niacin and other niacin metabolites in plasma and have optimized the detection
process, which would be applicated in this study.
At the same time, studies have shown that pregnant women generally have multiple vitamin
deficiency during pregnancy, including plasma thiamine, vitamin A, vitamin B6, vitamin B12
and vitamin D. Therefore, in addition to detecting plasma niacin, this study will also
examine the plasma levels of the remaining multivitamins to further explore the impact of
nutritional deficiencies on the probability of recurrent miscarriage.