Study on Clinical Value of Vitamin D in Recurrent Spontaneous Abortion

Vitamin D Deficiency Clinical Trial

Official title:

The Role and Mechanism of Vitamin D in Recurrent Spontaneous Abortion Based on Maternal Fetal Interface Immune Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06002035
• Other study ID #: 2023002
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: July 25, 2023

Study information

• Verified date: August 2023
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1421
• Est. completion date: July 25, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Recurrence
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Binom Vitamin D drops
Take 30 drops (relative to 1ml) once a day, directly into the mouth or with complementary foods added

Locations

Country	Name	City	State
China	Jianmei Xia	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jianmei Xia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The difference of age in different number of spontaneous abortions	Record patients' age through initial visit.	one day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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