NCT06002035

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,421

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

July 31, 2023

Last Update Submit

August 17, 2023

Conditions

Vitamin D DeficiencyRecurrent Spontaneous Abortion

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • The difference of age in different number of spontaneous abortions

    one day

  • The difference of BMI in different number of spontaneous abortion

    one day

  • The difference of uterine artery resistance parameter S/D in different number of spontaneous abortions

    dynamic monitoring, average of half of a year

  • The abnormality of some embryonic chromosomes tested voluntarily in spontaneous abortions

    a month

  • The change of plasma VD content in spontaneous abortions before and after supplying vitamin D

    average of 1 year

  • +1 more secondary outcomes

Study Arms (3)

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

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

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

Interventions

Binom Vitamin D dropsDIETARY_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)patients with a spontaneous abortion(SA1)patients without spontaneous abortion(SA0)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianmei Xia

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Vitamin D DeficiencyAbortion, Spontaneous

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jianmei Xia

    First People's Hospital of Hangzhou

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Chief Physician

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 21, 2023

Study Start

January 1, 2021

Primary Completion

June 30, 2023

Study Completion

July 25, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

CN(1)