Study on Clinical Value of Vitamin D in Recurrent Spontaneous Abortion

NCT ID: NCT06002035

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1421 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-07-25

Brief Summary

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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

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Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes tested voluntarily, plasma VD content and the level of anticardiolipin antibody.

Conditions

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Vitamin D Deficiency Recurrent Spontaneous Abortion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Binom Vitamin D drops

Intervention Type DIETARY_SUPPLEMENT

Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added

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.

Binom Vitamin D drops

Intervention Type DIETARY_SUPPLEMENT

Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added

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.

Binom Vitamin D drops

Intervention Type DIETARY_SUPPLEMENT

Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added

Interventions

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Binom Vitamin D drops

Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of patients without spontaneous abortion;
* Clinical diagnosis of patients with a spontaneous abortion;
* Clinical diagnosis of patients with recurrent pontaneous abortions;

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jianmei Xia

OTHER

Sponsor Role lead

Responsible Party

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Jianmei Xia

Deputy Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jianmei Xia

Role: STUDY_DIRECTOR

First People's Hospital of Hangzhou

Locations

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Jianmei Xia

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2023002

Identifier Type: -

Identifier Source: org_study_id

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