Nutritional Deficiencies About Recurrent Miscarriage

March 14, 2022 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Recurrent abortion population without confirmed diagnosis of known causes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
recurrent abortion
women of childbearing age who have spontaneous abortion within 20 weeks of pregnancy for 2 or more consecutive times.
Diagnostic test: Detection of niacin and other vitamins in plasma
Detection of niacin and other vitamins in plasma
normal pregnancy history
Women of childbearing age who had a normal pregnancy history and are not in pregnancy status now.
Diagnostic test: Detection of niacin and other vitamins in plasma
Detection of niacin and other vitamins in plasma
general population
Women of childbearing age in general examination.
Diagnostic test: Detection of niacin and other vitamins in plasma
Detection of niacin and other vitamins in plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma niacin levels in the enrolled population.
Time Frame: 2019-11 to 2020-1
2019-11 to 2020-1

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma thiamine, vitamin A, vitamin B6, vitamin B12, vitamin D levels of the enrolled population
Time Frame: 2019-11 to 2020-1
2019-11 to 2020-1
full exon sequence of the enrolled population
Time Frame: 2019-11 to 2020-1
2019-11 to 2020-1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Director: Qi Yu, Professor, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ACTUAL)

November 12, 2021

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (ACTUAL)

August 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yuqi2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The results of outcomes may be presented after the study has been finished.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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