Vitamin D DeficiencyNCT06002035
Study on Clinical Value of Vitamin D in Recurrent Spontaneous Abortion
An observational study of Vitamin D Deficiency and Recurrent Spontaneous Abortion, run by Jianmei Xia at 1 site in China.
Trial summary
The observational study is to compare vitamin D deficiency and related indicators among different spontaneous abortions in describe female reproductive health.The main question aim to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin D. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Recurrent Spontaneous Abortion
- What is being tested?
- Binom Vitamin D drops
- How many people
- 1,421 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 25 Jul 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women of childbearing age visited the RSA specialty clinic of Hangzhou First People's Hospital from January 2021 to June 2023, conducting a prospective clinical study.
Who may be able to join
- Clinical diagnosis of patients without spontaneous abortion;
- Clinical diagnosis of patients with a spontaneous abortion;
- Clinical diagnosis of patients with recurrent pontaneous abortions;
Who cannot join
- Patients with chromosomal abnormalities in RSA couples, such as balanced translocation;
- Patients who take VD preparations or related VD supplements within 3 months before treatment;
- Patients with a combination of certain malignant tumors and severe mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role and Mechanism of Vitamin D in Recurrent Spontaneous Abortion Based on Maternal Fetal Interface Immune Tolerance
The observational study is to compare vitamin D deficiency and related indicators among different spontaneous abortions in describe female reproductive health.The main question aim to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin D.
Participants, who visit the RSA specialty clinic, will provide medical history information, regularly exam based on the condition, following up on pregnancy status.Participants will be asked to supply vitamin D preparation and do moderate exercise outdoors, comparing the effect after treatment.
Read the detailed description
Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes tested voluntarily, plasma VD content and the level of anticardiolipin antibody.
- Being tested
- Binom Vitamin D drops
- Medical subject headings
- Vitamin D Deficiency, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binom Vitamin D dropsDietary supplement
Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added
| Study group | Role | What they receive |
|---|---|---|
| patients without spontaneous abortion(SA0) | The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added. Receives: Dietary Supplement: Binom Vitamin D drops | |
| patients with a spontaneous abortion(SA1) | The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added. Receives: Dietary Supplement: Binom Vitamin D drops | |
| patients with RSA (SA2 and above) | The patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added. Receives: Dietary Supplement: Binom Vitamin D drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes1
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as empty sac which refers to the absence of a fetal sac or embryo bud (the amniotic sac is empty).
Measured: average of 1 year
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes2
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as biochemical pregnancy which refers to the phenomenon where the sperm and egg combine but fail to return to the uterus for implantation, leading to miscarriage along with menstruation.
Measured: average of half of a year
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes3
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as loss of fetal heart rate which refers to the cessation of fetal heartbeat during pregnancy leading to miscarriage.
Measured: average of half of a year
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes4
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as spontaneous miscarriage in large months (greater than 12 weeks but less than 28 weeks) which refers to the cause of fetal death in the uterus, vaginal bleeding or flowing and abdominal pain leading to miscarriage.
Measured: average of half of a year
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes5
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as failure of fetal heart rate which the inability of the fetus to detect heartbeat leading to miscarriage.
Measured: average of half of a year
Secondary outcomes (6)
The difference of age in different number of spontaneous abortions
Record patients' age through initial visit.
Measured: one day
The difference of BMI in different number of spontaneous abortion
Record patients' height and weight through initial visit, and then calculate according to BMI formula.
Measured: one day
The difference of uterine artery resistance parameter S/D in different number of spontaneous abortions
Use a three-dimensional ultrasound diagnostic instrument(GEVoluson-E10 or E8, USA) with a frequency of 5-9 MHz intracavity probe (non pregnancy) or 3-7 MHz abdominal probe (pregnancy) to examine bilateral S/D. Unpregnant patients were in mid luteal phase(5-7 days after ovulation), while pregnant patients were at 10 weeks of pregnancy.
Measured: dynamic monitoring, average of half of a year
The abnormality of some embryonic chromosomes tested voluntarily in spontaneous abortions
use SNP gene chips to detect the embryonic chromosomes in spontaneous abortion; extract the genomic DNA of aborted embryo tissue, perform whole genome chromosome detection and determine whether the corresponding fragment or site is abnormal.
Measured: a month
The change of plasma VD content in spontaneous abortions before and after supplying vitamin D
VD content was detected by liquid chromatography-tandem mass spectrometry using DISIGNS reagent. Dynamically monitor plasma VD at least twice every two months before and after treatment, and monitor early, mid, and late pregnancy each once after conception.
Measured: average of 1 year
The change of the level of plasma anticardiolipin antibody in spontaneous abortions before and after supplying vitamin D
ACA level was detected by enzyme-linked immunosorbent assay using EUROIMMUN reagent. dynamically monitor plasma anticardiolipin antibody at least twice every two months before and after treatment, and monitor early, mid, and late pregnancy each once after conception.
Measured: average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2021
- Primary completion30 Jun 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianmei Xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianmei Xia, First People's Hospital of Hangzhou
- Investigators
- Jianmei Xia, Study director, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002035
- Sponsor's protocol ID
- 2023002
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Mechanism of Vitamin D in Recurrent Spontaneous Abortion Based on Maternal Fetal Interface Immune Tolerance
- ClinicalTrials.gov ID
- NCT06002035
- Acronym / sponsor ID
- 2023002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,421 participants (actual)
- Lead sponsor
- Jianmei XiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 21 Aug 2023 (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 observational study is to compare vitamin D deficiency and related indicators among different spontaneous abortions in describe female reproductive health.The main question aim to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin D.
Participants, who visit the RSA specialty clinic, will provide medical history information, regularly exam based on the condition, following up on pregnancy status.Participants will be asked to supply vitamin D preparation and do moderate exercise outdoors, comparing the effect after treatment.
Detailed description
Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes tested voluntarily, plasma VD content and the level of anticardiolipin antibody.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients without spontaneous abortion(SA0) | – | Dietary Supplement: Binom Vitamin D dropsThe patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added. |
| patients with a spontaneous abortion(SA1) | – | Dietary Supplement: Binom Vitamin D dropsThe patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added. |
| patients with RSA (SA2 and above) | – | Dietary Supplement: Binom Vitamin D dropsThe patients with VD deficiency or insufficiency take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women of childbearing age visited the RSA specialty clinic of Hangzhou First People's Hospital from January 2021 to June 2023, conducting a prospective clinical study.
Key inclusion criteria (3 listed)
- Clinical diagnosis of patients without spontaneous abortion;
- Clinical diagnosis of patients with a spontaneous abortion;
- Clinical diagnosis of patients with recurrent pontaneous abortions;
Key exclusion criteria (3 listed)
- Patients with chromosomal abnormalities in RSA couples, such as balanced translocation;
- Patients who take VD preparations or related VD supplements within 3 months before treatment;
- Patients with a combination of certain malignant tumors and severe mental illness.
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 |
|---|---|---|
| Binom Vitamin D dropsTake 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added | Dietary supplement | patients with RSA (SA2 and above), patients with a spontaneous abortion(SA1), patients without spontaneous abortion(SA0) |
Primary outcome
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes1
Time frame: average of 1 year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as empty sac which refers to the absence of a fetal sac or embryo bud (the amniotic sac is empty).
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes2
Time frame: average of half of a year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as biochemical pregnancy which refers to the phenomenon where the sperm and egg combine but fail to return to the uterus for implantation, leading to miscarriage along with menstruation.
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes3
Time frame: average of half of a year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as loss of fetal heart rate which refers to the cessation of fetal heartbeat during pregnancy leading to miscarriage.
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes4
Time frame: average of half of a year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as spontaneous miscarriage in large months (greater than 12 weeks but less than 28 weeks) which refers to the cause of fetal death in the uterus, vaginal bleeding or flowing and abdominal pain leading to miscarriage.
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes5
Time frame: average of half of a year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as failure of fetal heart rate which the inability of the fetus to detect heartbeat leading to miscarriage.
6 secondary outcomes
The difference of age in different number of spontaneous abortions
Time frame: one day
The difference of BMI in different number of spontaneous abortion
Time frame: one day
The difference of uterine artery resistance parameter S/D in different number of spontaneous abortions
Time frame: dynamic monitoring, average of half of a year
The abnormality of some embryonic chromosomes tested voluntarily in spontaneous abortions
Time frame: a month
The change of plasma VD content in spontaneous abortions before and after supplying vitamin D
Time frame: average of 1 year
The change of the level of plasma anticardiolipin antibody in spontaneous abortions before and after supplying vitamin D
Time frame: average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
Jianmei Xia study director
First People's Hospital of Hangzhou
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 Vitamin D Deficiency and Recurrent Spontaneous Abortion, run by Jianmei Xia 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes1 (time frame: average of 1 year). The study lists 5 primary outcomes in all. 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 21 Aug 2023.