NCT04064931

Nutritional Deficiencies About Recurrent Miscarriage

Study on Nutritional Deficiencies and Related Factors in Patients With Recurrent Miscarriage

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Abortion, Habitual
• Nutritional Status

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Detection of niacin and other vitamins in plasma	Detection of niacin and other vitamins in plasma

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-11-12
• Completion: 2022-11-01
• First posted: 2019-08-22
• Last updated: 2022-03-15

Locations

1 site across 1 country: China