Vitamin D DeficiencyNCT05824897
The Cohort Study of the Correlation Between Serum 25(OH)D Level and Pregnancy Outcome
An observational study of Vitamin D Deficiency and Recurrent Miscarriage, run by Aimin Zhao at 1 site in China.
Trial summary
The objective of this single-center prospective observational study is to clarify the trend of maternal serum 25(OH)D levels before pregnancy and during pregnancy, and to explore the correlation between serum 25(OH)D levels and subsequent pregnancy outcomes of patients with abortion, so as to provide certain… Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Recurrent Miscarriage, Pregnancy Related
- What is being tested?
- Serum levels of vitamin D
- How many people
- 171 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Jan 2024
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women of childbearing age who are ready to become pregnant or already pregnant.
Who may be able to join
- ≥20 years old
- The chromosome karyotype of the couple is normal
- Color ultrasound examination results indicated that there was no organic disease related to reproductive tract
- No serious complications of surgery and medicine
- Agree and voluntarily sign informed consent
Who cannot join
- There are contraindications to pregnancy
- the initiative to give up pregnancy
- Severe medical and surgical complications, for example, liver disease was defined as serum alanine aminotransferase [ALT] or aspartic aminotransferase [AST]>3 x upper normal limit [ULN] after repeated testing
- Concomitant malignant tumor, malignant tumor developed in the last 5 years (except for the skin squamous basal cell carcinoma that has been removed and considered cured). Subjects who developed malignant tumors more than 5 years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer were eligible if they could demonstrate that their cervical cancer had been cone removed or cured within the past 3 years
- Known human immunodeficiency virus (HIV) positive and/or hepatitis B surface antigen or hepatitis C virus antibody positive at screening visit
- With a history of chronic infections such as mycoplasma, chlamydia, cryptococcus, and invasive fungal infections should be discussed with the principal investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Renyi Zhou, 86-15151561775, klyjzrysfmyn@163.com
About this study
The objective of this single-center prospective observational study is to clarify the trend of maternal serum 25(OH)D levels before pregnancy and during pregnancy, and to explore the correlation between serum 25(OH)D levels and subsequent pregnancy outcomes of patients with abortion, so as to provide certain scientific evidence for finding the optimal serum level of 25(OH)D and optimal vitamin D supplementation to maintain a healthy pregnancy.
Read the detailed description
Women of reproductive age who meet the inclusion criteria are recruited from the outpatient department of Renji Hospital from November 2022 to December 2023. Subjects fill in the basic information at the outpatient clinic. After being included in the study, peripheral blood is collected before and during the first trimester (< 10 weeks), second trimester (22-24 weeks) and third trimester (32 weeks) to detect 25(OH)D, calcium, phosphorus and PTH levels. B-ultrasound examination is performed before pregnancy to record endometrial thickness, endometrial hemodynamic index (PI, RI and S/D) and uterine arterial hemodynamic index (PI, RI and S/D) during the luteal phase. Data are comprehensively analyzed through questionnaire form filling, laboratory examination, and clinical information records including pregnancy outcomes (final live birth rate, cesarean section rate, pregnancy loss rate, etc.), obstetric complications, and neonatal delivery information.
- Being tested
- Serum levels of vitamin D
- Keywords
- vitamin D, pregnancy, recurrent spontaneous abortion
- Medical subject headings
- Vitamin D Deficiency, Abortion, Habitual, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum levels of vitamin DOther
Subjects in this study are grouped according to baseline serum levels of 25(OH)D. The serum level of total 25(OH)D ≥30ng/ml (75nM) is sufficient, 20-30ng/ml (50-75 nm) is insufficient, and less than 20ng/ml (50nM) is deficient.
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy loss
After a positive urinary hCG pregnancy test at home or clinically, there were no clinical signs of pregnancy on subsequent ultrasound or signs of pregnancy were lost after ultrasound confirmation.
Measured: Up to 28 weeks
Secondary outcomes (5)
Live birth
A live baby born after 23 weeks of gestation
Measured: Up to 20 weeks
Premature birth
Delivery between 28 and 37 weeks gestation
Measured: 9 weeks
Preeclampsia
New hypertension (blood pressure greater than 140/90 mmHg) after 20 weeks of gestation combined with new unexplained urinary protein greater than or equal to 300mg/24h or a urinary protein/creatinine ratio greater than or equal to 0.3 or other conditions
Measured: 20 weeks
Gestational diabetes mellitus
Perform a 75-g OGTT with plasma glucose measurement when patient is fasting and at 1 and 2 h, at 24-to-28-wk gestation in women not previously diagnosed with overt diabetes
The diagnosis of GDM is made when any one of the following plasma glucose values are met or exceeded:
Fasting: 92 mg/dL
- h: 180 mg/dL
- h: 153 mg/dL
Measured: 4 weeks
Fetal growth restriction
Fetal weight below the 10th percentile of the mean weight for its gestational age or below 2 standard deviations of the mean weight
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aimin Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aimin Zhao, RenJi Hospital
- Investigators
- Aimin Zhao, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824897
- Sponsor's protocol ID
- IIT-2023-0011
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cohort Study of the Correlation Between Serum 25(OH)D Level and Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT05824897
- Acronym / sponsor ID
- IIT-2023-0011
- Keywords
- vitamin D, pregnancy, recurrent spontaneous abortion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Aimin ZhaoUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 24 Apr 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 objective of this single-center prospective observational study is to clarify the trend of maternal serum 25(OH)D levels before pregnancy and during pregnancy, and to explore the correlation between serum 25(OH)D levels and subsequent pregnancy outcomes of patients with abortion, so as to provide certain scientific evidence for finding the optimal serum level of 25(OH)D and optimal vitamin D supplementation to maintain a healthy pregnancy.
Detailed description
Women of reproductive age who meet the inclusion criteria are recruited from the outpatient department of Renji Hospital from November 2022 to December 2023. Subjects fill in the basic information at the outpatient clinic. After being included in the study, peripheral blood is collected before and during the first trimester (< 10 weeks), second trimester (22-24 weeks) and third trimester (32 weeks) to detect 25(OH)D, calcium, phosphorus and PTH levels. B-ultrasound examination is performed before pregnancy to record endometrial thickness, endometrial hemodynamic index (PI, RI and S/D) and uterine arterial hemodynamic index (PI, RI and S/D) during the luteal phase. Data are comprehensively analyzed through questionnaire form filling, laboratory examination, and clinical information records including pregnancy outcomes (final live birth rate, cesarean section rate, pregnancy loss rate, etc.), obstetric complications, and neonatal delivery information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women of childbearing age who are ready to become pregnant or already pregnant.
Key inclusion criteria (5 listed)
- ≥20 years old
- The chromosome karyotype of the couple is normal
- Color ultrasound examination results indicated that there was no organic disease related to reproductive tract
- No serious complications of surgery and medicine
- Agree and voluntarily sign informed consent
Key exclusion criteria (6 listed)
- There are contraindications to pregnancy
- the initiative to give up pregnancy
- Severe medical and surgical complications, for example, liver disease was defined as serum alanine aminotransferase [ALT] or aspartic aminotransferase [AST]>3 x upper normal limit [ULN] after repeated testing
- Concomitant malignant tumor, malignant tumor developed in the last 5 years (except for the skin squamous basal cell carcinoma that has been removed and considered cured). Subjects who developed malignant tumors more than 5 years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer were eligible if they could demonstrate that their cervical cancer had been cone removed or cured within the past 3 years
- Known human immunodeficiency virus (HIV) positive and/or hepatitis B surface antigen or hepatitis C virus antibody positive at screening visit
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 |
|---|---|---|
| Serum levels of vitamin DSubjects in this study are grouped according to baseline serum levels of 25(OH)D. The serum level of total 25(OH)D ≥30ng/ml (75nM) is sufficient, 20-30ng/ml (50-75 nm) is insufficient, and less than 20ng/ml (50nM) is deficient. | Other | – |
Primary outcome
pregnancy loss
Time frame: Up to 28 weeks
After a positive urinary hCG pregnancy test at home or clinically, there were no clinical signs of pregnancy on subsequent ultrasound or signs of pregnancy were lost after ultrasound confirmation.
5 secondary outcomes
Live birth
Time frame: Up to 20 weeks
Premature birth
Time frame: 9 weeks
Preeclampsia
Time frame: 20 weeks
Gestational diabetes mellitus
Time frame: 4 weeks
Fetal growth restriction
Time frame: Up to 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Aimin Zhao, MD principal investigator
RenJi Hospital
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 Miscarriage, run by Aimin Zhao 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renyi Zhou (86-15151561775, klyjzrysfmyn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy loss (time frame: Up to 28 weeks). 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 24 Apr 2023.