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Nutritional Deficiencies About Recurrent Miscarriage

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04064931
Enrollment
1000
Registered
2019-08-22
Start date
2019-08-01
Completion date
2022-11-30
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Habitual, Nutritional Status

Keywords

recurrent miscarriage, vitamins

Brief 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.

Interventions

DIAGNOSTIC_TESTDetection of niacin and other vitamins in plasma

Detection of niacin and other vitamins in plasma

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Research group 1: Recurrent abortion group: women of childbearing age who have spontaneous abortion within 20 weeks of pregnancy for 2 or more consecutive times. Control group: 1) Women of childbearing age who had a normal pregnancy history and are not in pregnancy status now. 2) Women of childbearing age in general examination.

Exclusion criteria

* patients with confirmed causes unrelated to nutritional deficiencies, including 1. Both husband and wife have been diagnosed with chromosomal abnormalities or fetal chorionic chromosomal abnormalities; 2. The patient has been diagnosed with uterine abnormalities; 3. vaginal bacterial infection or chlamydial infection; 4. antiphospholipid antibody syndrome; 5. Other immune system diseases (hypothyroidism, PCOS, hyperprolactinemia); 6. ovarian function decline (FSH\>10mIU/ml); 7. Cervical insufficiency5.3 Exit criteria: After being selected, the researcher was withdrawn due to various considerations.

Design outcomes

Primary

MeasureTime frame
Plasma niacin levels in the enrolled population.2019-11 to 2020-1

Secondary

MeasureTime frame
plasma thiamine, vitamin A, vitamin B6, vitamin B12, vitamin D levels of the enrolled population2019-11 to 2020-1
full exon sequence of the enrolled population2019-11 to 2020-1

Countries

China

Contacts

Primary ContactQi Yu, Professor
yuqi2008001@sina.com18612671865
Backup ContactFangying Chen, MD
18800106869@163.com18800106869

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026