Vitamin DEarly Phase 1NCT05208827
Vitamin D Supplementation for the Prevention of GDM
A Early Phase 1 study testing Vitamin D3 in people with Vitamin D and Gestational Diabetes, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
This study was a double-blind multicenter randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D, Gestational Diabetes
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2025
- Phase
- Early Phase 1
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who are 8 to 14 weeks pregnant ; ② 18 to 45 years old; ③ Pregnant women at high risk of GDM (meeting any of the following conditions) : A) BMI ≥24 kg/m2 before or during pregnancy; B) family history of diabetes or GDM; C) Previous pregnancy diagnosed as GDM; D) with a history of macrosomia (≥4000 g); E) A history of abnormal glucose tolerance: 5.7-6.4% hBA1c or 6.1-7.0 mmol/L fasting blood glucose.
- Sign informed consent. -
Who cannot join
- Patients with a history of diabetes or currently diagnosed diabetes (including type 1 and type 2 diabetes);
- HBA1c ≥6.5% or fasting blood glucose \& GT;7.0 mmol/L with obvious symptoms of diabetes;
- Patients with current or past abnormalities in calcium metabolism (hypoparathyroidism/hyperthyroidism, kidney stones), high urinary calcium or hypercalcemia;
- Daily VitD intake \& GT;800 IU. ⑤ Suffering from serious chronic diseases (heart, lung, liver, kidney and other dysfunction) or mental illness;
- They cannot walk 100 meters safely; 7. Multiple pregnancies or assisted reproduction; ⑧ need complex diet;
- Cannot speak Mandarin fluently; ⑩ Those who are participating in other clinical trials or who are considered unsuitable for clinical trials by researchers for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Luyang Han, Dr., 18867106248 ext. +86, 524519232@163.com
About this study
Official title: A Multicenter Randomized Controlled Study of Vitamin D Supplementation in Pregnant Women for the Prevention of Gestational Diabetes
This study was a double-blind multicenter randomized controlled study.
Read the detailed description
This study intends to adopt a randomized controlled study design, and randomly divide pregnant women at high risk of GDM into intervention group (VitD3:1600 IU/ day) (n=800) and control group (placebo:2 tablets/day) (n=800) until the end of delivery. The risk of GDM in pregnant women of the two groups was compared, the preventive effect of high-dose VitD supplementation during pregnancy on different subtypes of GDM was determined, and the effects of VitD supplementation on VitD nutritional status during pregnancy and birth outcome and health of offspring were explored, so as to provide evidence-based basis for rational VitD supplementation during pregnancy.
- Conditions
- Vitamin D, Gestational Diabetes
- Being tested
- Vitamin D3, The placebo(not contain vitamin D)
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Participants began to take medication at 12 weeks of gestation, and participants in the second trimester began to take medication at the time point of enrollment.The dosage is 2 tablets per day, taken orally for 12 weeks.The drug in the intervention group was fat-soluble vitamin D3, which was produced by Sinopril Holding Starfish Pharmaceutical (Xiamen) Co., LTD. Each tablet contained 800 units of vitamin D3, vegetable oil and starch as auxiliary material.
The placebo(not contain vitamin D)Drug
Pills that looked, colored and tasted like vitamin D in the control group, but contained only starch and vegetable oil and no vitamin D.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily Receives: Drug: Vitamin D3 |
| Control Group | Placebo comparator | The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value) Receives: Drug: The placebo(not contain vitamin D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational diabetes
We will judge whether patients have gestational diabetes based on OGTT results (fasting, 1-hour, 2-hour blood glucose results) .
Measured: At 24-28 weeks of gestation
Secondary outcomes (3)
Newborn birth weight
Weight of newborn at birth
Measured: immediately after delivery
Gestational age
Determine the gestational age of the woman and whether preterm birth exists
Measured: immediately after delivery
Weight gain during pregnancy
Weigh the pregnant woman on the first day after delivery and subtract her weight before pregnancy from the birth examination book
Measured: First day after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin DStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danqing Chen, doctor, Study chair, Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208827
- Sponsor's protocol ID
- GDM20211008
- Status last verified
- Jan 2022
- First submitted
- 24 Nov 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study of Vitamin D Supplementation in Pregnant Women for the Prevention of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT05208827
- Acronym / sponsor ID
- GDM20211008
- Conditions
- Vitamin D, Gestational Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Jan 2022 (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.
This study was a double-blind multicenter randomized controlled study.
Detailed description
This study intends to adopt a randomized controlled study design, and randomly divide pregnant women at high risk of GDM into intervention group (VitD3:1600 IU/ day) (n=800) and control group (placebo:2 tablets/day) (n=800) until the end of delivery. The risk of GDM in pregnant women of the two groups was compared, the preventive effect of high-dose VitD supplementation during pregnancy on different subtypes of GDM was determined, and the effects of VitD supplementation on VitD nutritional status during pregnancy and birth outcome and health of offspring were explored, so as to provide evidence-based basis for rational VitD supplementation during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled study design
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Vitamin D3Take two tablets once a day.Each tablet contains 800 units of vitamin D3, for a total of 1600 units taken orally daily |
| Control Group | Placebo comparator | Drug: The placebo(not contain vitamin D)The control group received the same packaged, similar-looking, similar-tasting placebo from the same manufacturer, containing starch, peanut oil (no pharmaceutical value) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women who are 8 to 14 weeks pregnant ; ② 18 to 45 years old; ③ Pregnant women at high risk of GDM (meeting any of the following conditions) : A) BMI ≥24 kg/m2 before or during pregnancy; B) family history of diabetes or GDM; C) Previous pregnancy diagnosed as GDM; D) with a history of macrosomia (≥4000 g); E) A history of abnormal glucose tolerance: 5.7-6.4% hBA1c or 6.1-7.0 mmol/L fasting blood glucose.
Key exclusion criteria (6 listed)
- Patients with a history of diabetes or currently diagnosed diabetes (including type 1 and type 2 diabetes);
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 |
|---|---|---|
| Vitamin D3Participants began to take medication at 12 weeks of gestation, and participants in the second trimester began to take medication at the time point of enrollment.The dosage is 2 tablets per day, taken orally for 12 weeks.The drug in the intervention group was fat-soluble vitamin D3, which was produced by Sinopril Holding Starfish Pharmaceutical (Xiamen) Co., LTD. Each tablet contained 800 units of vitamin D3, vegetable oil and starch as auxiliary material. | Drug | Experimental group |
| The placebo(not contain vitamin D)Pills that looked, colored and tasted like vitamin D in the control group, but contained only starch and vegetable oil and no vitamin D. | Drug | Control Group |
Primary outcome
Gestational diabetes
Time frame: At 24-28 weeks of gestation
We will judge whether patients have gestational diabetes based on OGTT results (fasting, 1-hour, 2-hour blood glucose results) .
3 secondary outcomes
Newborn birth weight
Time frame: immediately after delivery
Gestational age
Time frame: immediately after delivery
Weight gain during pregnancy
Time frame: First day after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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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.
Danqing Chen, doctor study chair
Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D3 in people with Vitamin D and Gestational Diabetes, run by Women's Hospital School Of Medicine Zhejiang University 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 2 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 26 Jan 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Luyang Han, doctor (18867106248, 524519232@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational diabetes (time frame: At 24-28 weeks of gestation). 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 26 Jan 2022.