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Nutritional Deficiencies About Recurrent Miscarriage

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ClinicalTrials.gov Identifier: NCT04064931
Recruitment Status : Unknown
Verified March 2021 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : August 22, 2019
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Abortion, Habitual Nutritional Status Diagnostic Test: Detection of niacin and other vitamins in plasma

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Study on Nutritional Deficiencies and Related Factors in Patients With Recurrent Miscarriage
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : November 12, 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma niacin levels in the enrolled population. [ Time Frame: 2019-11 to 2020-1 ]

Secondary Outcome Measures :
  1. plasma thiamine, vitamin A, vitamin B6, vitamin B12, vitamin D levels of the enrolled population [ Time Frame: 2019-11 to 2020-1 ]
  2. full exon sequence of the enrolled population [ Time Frame: 2019-11 to 2020-1 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Recurrent abortion population without confirmed diagnosis of known causes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064931


Contacts
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Contact: Qi Yu, Professor 18612671865 yuqi2008001@sina.com
Contact: Fangying Chen, MD 18800106869 18800106869@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100730
Contact: Qi Yu, professor    18612671865    yuqi2008001@sina.com   
Contact: Fangying Chen, MD    18800106869    18800106869@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Director: Qi Yu, Professor Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04064931    
Other Study ID Numbers: yuqi2019
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The results of outcomes may be presented after the study has been finished.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
recurrent miscarriage
vitamins
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Malnutrition
Pregnancy Complications
Nutrition Disorders
Niacin
Vitamins
Micronutrients
 Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex