Abortion, HabitualNCT04064931
Nutritional Deficiencies About Recurrent Miscarriage
An observational study of Abortion, Habitual and Nutritional Status, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Habitual, Nutritional Status
- What is being tested?
- Detection of niacin and other vitamins in plasma
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to Nov 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Recurrent abortion population without confirmed diagnosis of known causes
Who may be able to join
- 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.
Who cannot join
- patients with confirmed causes unrelated to nutritional deficiencies, including
- Both husband and wife have been diagnosed with chromosomal abnormalities or fetal chorionic chromosomal abnormalities;
- The patient has been diagnosed with uterine abnormalities;
- vaginal bacterial infection or chlamydial infection;
- antiphospholipid antibody syndrome;
- Other immune system diseases (hypothyroidism, PCOS, hyperprolactinemia);
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- ovarian function decline (FSH>10mIU/ml);
- Cervical insufficiency5.3 Exit criteria:
- After being selected, the researcher was withdrawn due to various considerations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Qi Yu, professor, 18612671865, yuqi2008001@sina.com
Fangying Chen, MD, 18800106869, 18800106869@163.com
About this study
Official title: 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.
Read the 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
- Being tested
- Detection of niacin and other vitamins in plasma
- Keywords
- recurrent miscarriage, vitamins
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of niacin and other vitamins in plasmaDiagnostic test
Detection of niacin and other vitamins in plasma
| Study group | Role | What they receive |
|---|---|---|
| recurrent abortion | women of childbearing age who have spontaneous abortion within 20 weeks of pregnancy for 2 or more consecutive times. Receives: Diagnostic Test: 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. Receives: Diagnostic Test: Detection of niacin and other vitamins in plasma | |
| general population | Women of childbearing age in general examination. Receives: Diagnostic Test: Detection of niacin and other vitamins in plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma niacin levels in the enrolled population.
Measured: 2019-11 to 2020-1
Secondary outcomes (2)
plasma thiamine, vitamin A, vitamin B6, vitamin B12, vitamin D levels of the enrolled population
Measured: 2019-11 to 2020-1
full exon sequence of the enrolled population
Measured: 2019-11 to 2020-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Aug 2019
- Primary completion12 Nov 2021
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, HabitualStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qi Yu, Professor, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064931
- Sponsor's protocol ID
- yuqi2019
- Status last verified
- Mar 2021
- First submitted
- 20 Aug 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of outcomes may be presented after the study has been finished.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Nutritional Deficiencies and Related Factors in Patients With Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT04064931
- Acronym / sponsor ID
- yuqi2019
- Conditions
- Abortion, Habitual, Nutritional Status
- Keywords
- recurrent miscarriage, vitamins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- Nov 2022 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| recurrent abortion | – | Diagnostic Test: Detection of niacin and other vitamins in plasmawomen of childbearing age who have spontaneous abortion within 20 weeks of pregnancy for 2 or more consecutive times. |
| normal pregnancy history | – | Diagnostic Test: Detection of niacin and other vitamins in plasmaWomen of childbearing age who had a normal pregnancy history and are not in pregnancy status now. |
| general population | – | Diagnostic Test: Detection of niacin and other vitamins in plasmaWomen of childbearing age in general examination. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Recurrent abortion population without confirmed diagnosis of known causes
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- patients with confirmed causes unrelated to nutritional deficiencies, including
- After being selected, the researcher was withdrawn due to various considerations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of niacin and other vitamins in plasmaDetection of niacin and other vitamins in plasma | Diagnostic test | general population, normal pregnancy history, recurrent abortion |
Primary outcome
Plasma niacin levels in the enrolled population.
Time frame: 2019-11 to 2020-1
2 secondary outcomes
plasma thiamine, vitamin A, vitamin B6, vitamin B12, vitamin D levels of the enrolled population
Time frame: 2019-11 to 2020-1
full exon sequence of the enrolled population
Time frame: 2019-11 to 2020-1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Undecided. The results of outcomes may be presented after the study has been finished.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Yu, Professor study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, Habitual and Nutritional Status, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Yu, Professor (18612671865, yuqi2008001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma niacin levels in the enrolled population. (time frame: 2019-11 to 2020-1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.