Study on Clinical Value of Vitamin D in Recurrent Spontaneous Abortion

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Recurrent Spontaneous Abortion
• Intervention / Treatment: Dietary supplement: Binom Vitamin D drops

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 Type: Observational
• Enrollment (Actual): 1421

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Jianmei Xia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Dietary supplement: Binom Vitamin D drops; 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.	Dietary supplement: Binom Vitamin D drops; 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.	Dietary supplement: Binom Vitamin D drops; Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	average of half of a year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of age in different number of spontaneous abortions	Record patients' age through initial visit.	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.	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.	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.	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.	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.	average of 1 year

Collaborators and Investigators

• Sponsor: Jianmei Xia
• Investigators: Study Director: Jianmei Xia, First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vitamin D Deficiency; Recurrence; Abortion, Spontaneous; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 2023002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No