Gestational DiabetesPhase 1/2NCT03037593
High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women
A Phase 1/2 study testing 4000 IU vitamin D3 in people with Gestational Diabetes, run by University of Minnesota at 1 site in United States.
Trial summary
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- 4000 IU vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to Jun 2020
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are currently pregnant and receiving prenatal care at the Women's Health Specialists Clinic (University of Minnesota Physicians) from either MD/DO or CNM providers
- Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)
- Subject possesses as least one of the following characteristics:
- BMI greater than or equal to 30 kg/m2
- History of gestational diabetes in a prior pregnancy
- History of infant with birth weight of 4500g or greater
- Subject is capable of giving informed consent
Who cannot join
- Age less than 18 years
- Multiple gestation pregnancies (twins, triplets or greater multiples)
- Vitamin D deficiency (defined as less than 20 ng/mL)
- Preexisting diabetes mellitus defined as either:
- pre-existing diagnosis prior to current pregnancy
- failure of three-hour glucose tolerance test in first trimester of pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.
Read the detailed description
Determine the effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.
Explore the effect of increased vitamin D supplementation (4000 IU daily + prenatal vitamin), compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic agents and/or insulin, and delivery outcomes among the subset of women who develop gestational diabetes.
- Conditions
- Gestational Diabetes
- Being tested
- 4000 IU vitamin D3
- Keywords
- Pregnancy, Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4000 IU vitamin D3Drug
Also called cholecalciferol
vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 4000 IU vitamin D3 +prenatal vitamin Receives: Drug: 4000 IU vitamin D3 |
| Control | No intervention | standard prenatal vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gestational diabetes
effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.
Measured: Baseline to Delivery of child
Secondary outcomes (5)
Prescription for insulin or oral hypoglycemic agents
Prescription for insulin or oral hypoglycemic agents
Measured: Baseline to Delivery of child
Mode of delivery
Natural or C-Section
Measured: Delivery of child
Birth weight
Weight in Kg
Measured: Delivery of Child
Apgar score
<7 at 5 minutes
Measured: Birth of child to 5 minutes
Shoulder Dystocia
Measured: Birth of child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Jun 2017
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Failure to recruit adequate patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This will be a randomized single-center study with a target study group of 300 women. Women will be followed from enrollment through the remainder of their pregnancy
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samantha Hoffman, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037593
- Sponsor's protocol ID
- 1611M98781
- Status last verified
- Oct 2019
- First submitted
- 27 Jan 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT03037593
- Acronym / sponsor ID
- 1611M98781
- Conditions
- Gestational Diabetes
- Keywords
- Pregnancy, Gestational Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure to recruit adequate patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- 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.
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.
Detailed description
Determine the effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.
Explore the effect of increased vitamin D supplementation (4000 IU daily + prenatal vitamin), compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic agents and/or insulin, and delivery outcomes among the subset of women who develop gestational diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a randomized single-center study with a target study group of 300 women. Women will be followed from enrollment through the remainder of their pregnancy
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: 4000 IU vitamin D34000 IU vitamin D3 +prenatal vitamin |
| Control | No intervention | –standard prenatal vitamin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women who are currently pregnant and receiving prenatal care at the Women's Health Specialists Clinic (University of Minnesota Physicians) from either MD/DO or CNM providers
- Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)
- Subject possesses as least one of the following characteristics:
- Subject is capable of giving informed consent
Key exclusion criteria (6 listed)
- Age less than 18 years
- Multiple gestation pregnancies (twins, triplets or greater multiples)
- Vitamin D deficiency (defined as less than 20 ng/mL)
- Preexisting diabetes mellitus defined as either:
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 |
|---|---|---|
| 4000 IU vitamin D3Also: cholecalciferolvitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin | Drug | Intervention |
Primary outcome
incidence of gestational diabetes
Time frame: Baseline to Delivery of child
effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.
5 secondary outcomes
Prescription for insulin or oral hypoglycemic agents
Time frame: Baseline to Delivery of child
Mode of delivery
Time frame: Delivery of child
Birth weight
Time frame: Delivery of Child
Apgar score
Time frame: Birth of child to 5 minutes
Shoulder Dystocia
Time frame: Birth of child
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Samantha Hoffman, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 4000 IU vitamin D3 in people with Gestational Diabetes, run by University of Minnesota at 1 site in United States.
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 7 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: withdrawn, as of the sponsor's last update on 1 Nov 2019. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of gestational diabetes (time frame: Baseline to Delivery of child). 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 1 Nov 2019.