Prediabetes study: Vitamin D
Official title Vitamin D and Type 2 Diabetes - Treat-To-Target
ClinicalTrials.gov ID: NCT07448974
What this study is testing
What is Vitamin D (Cholecalciferol)?
This is an investigational liquid supplement being studied to see if it helps control blood sugar in people with prediabetes. It is designed to raise vitamin D levels in the blood, which research suggests may play a role in how the body manages blood sugar.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether vitamin D helps keep blood sugar in a healthy range. It compares vitamin D to a pretend pill with no medicine.
- Who it's for
- You may be able to join if you are an adult aged 30 to 74 with prediabetes.
- What's involved
- You would take a pill once a week. You would wear a small device to track your blood sugar.
- Time commitment
- The study lasts about 18 months with regular visits and blood tests.
- Phase 3: a large, late-stage study
- Time commitment: about 18 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 74
You may be able to join if
- Fasting plasma glucose (FPG) 100-125 mg/dL, inclusive
- Hemoglobin A1c (HbA1c) 5.7-6.4%, inclusive
- Age 30-74 years, inclusive
- Body Mass Index ≥ 23.0 and ≤ 35.0 kg/m2
- Provision of signed and dated written informed consent prior to any study procedures.
You likely can't join if
- History of diabetes (ICD10 diabetes code E08.X through E13.X) or meeting a diabetes glycemic criterion at screening, as defined by the ADA guidelines...
- History (past 2 years) of hyperparathyroidism, symptomatic or asymptomatic (i.e., radiographic) nephrolithiasis or hypercalcemia.
- Any medical condition (past 2 years) that in the opinion of the site investigator may increase risk for nephrolithiasis or hypercalcemia during the...
- If older than 70 years, history (past 1 year) of a fall.
- Use of tanning devices within 12 weeks of the baseline visit and unwilling to stop use of tanning devices for the duration of the study.
- Use (past 6 months) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes) for any condition (e.g...
See the full eligibility criteria
Who can join
- Fasting plasma glucose (FPG) 100-125 mg/dL, inclusive
- Hemoglobin A1c (HbA1c) 5.7-6.4%, inclusive
- Age 30-74 years, inclusive
- Body Mass Index ≥ 23.0 and ≤ 35.0 kg/m2
- Provision of signed and dated written informed consent prior to any study procedures.
What rules you out
- History of diabetes (ICD10 diabetes code E08.X through E13.X) or meeting a diabetes glycemic criterion at screening, as defined by the ADA guidelines (FPG ≥ 126 mg/dL or HbA1c ≥ 6.5%).
- History (past 2 years) of hyperparathyroidism, symptomatic or asymptomatic (i.e., radiographic) nephrolithiasis or hypercalcemia.
- Any medical condition (past 2 years) that in the opinion of the site investigator may increase risk for nephrolithiasis or hypercalcemia during the trial (e.g., sarcoidosis).
- If older than 70 years, history (past 1 year) of a fall.
- Use of tanning devices within 12 weeks of the baseline visit and unwilling to stop use of tanning devices for the duration of the study. Medications and Supplements
- Use (past 6 months) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes) for any condition (e.g., prediabetes, diabetes, polycystic ovarian syndrome, MASLD, sleep...
- Current use of medications approved by the FDA for weight management (e.g., incretin receptor agonists) or planned use during the study.
- Use of supplements containing vitamin D at total doses higher than 1000 IU/day within 8 weeks of the baseline visit and unwillingness to limit vitamin D supplementation dosage to no higher than 1000 IU/day during the...
- Use of supplements containing calcium at total doses higher than 600 mg/day within 1 week of the baseline visit and unwillingness to limit calcium supplementation dosage to no higher than 600 mg/day during the study.
- Current use of medications or conditions (e.g., untreated celiac disease) that would interfere with the absorption or metabolism of vitamin D.
- Use of an anticonvulsant drug started within 6 months of screening. Stable regimen of anticonvulsants is allowed.
- History of intolerance to vitamin D supplements, allergic to any content of the study drug or unwilling to take vitamin D supplements (e.g., someone who eats a vegan diet and would object to the cholecalciferol...
- Severe symptomatic cardiovascular disease based on history (unstable angina, dyspnea on exertion, paroxysmal nocturnal dyspnea, arrhythmia, congestive heart failure NYHA class II or higher, claudication)
- History (past 1 year) of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft.
- History (past 1 year) of cerebrovascular disease (stroke, transient ischemic attack).
- Any type of cancer (past 5 years) except for basal cell skin cancer. Prostate cancer (for men over age 55) or well-differentiated thyroid cancer not expected to require treatment (except for suppression with thyroid...
- History (past 6 months) of treatment with oral (for \> 7 days) or intravenous glucocorticoids or disease likely to require oral or intravenous glucocorticoid therapy during the study.
- History (past 1 year) of substance abuse or unstable psychiatric disorder that in the opinion of the site investigator would impede competence or adherence with study procedures or hinder completion of the study or...
- History of bariatric surgery (e.g., Roux-en-Y gastric bypass, gastric sleeve) or planned bariatric surgery in the next 2 years.
- Extreme (over 18 hours) intermittent fasting diets because prolonged fasting downregulates CYP2R1 activity.
- A life-threatening event within 30 days of screening or currently planned major surgery.
- Any other active medical condition (including but not limited to liver disease, wasting illness, HIV, tuberculosis, oxygen-dependent chronic obstructive pulmonary disease, organ transplant, Cushing's syndrome) that in...
- Uncontrolled hypertension (systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg).
- Poor venous access. Laboratory Evaluation
- Serum liver transaminase higher than 3 times the normal range for the clinical site's laboratory, within 18 months of screening.
- Anemia (hematocrit \< 32 for women, \< 36 for men), whole blood transfusion (within 18 months of screening) or chronic requirement, whole blood donation (within 3 months of screening) or other condition (hemolysis...
- Low platelet count (\< 100,000) within 18 months of screening.
- Chronic kidney disease, defined as estimated glomerular filtration rate [GFR] \< 50 mL/min per 1.73 m2 from creatinine level and GFR calculated by the new Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)...
- Hypercalcemia, defined as serum calcium concentration ≥ upper limit of normal within 18 months of screening.
- Hypercalciuria, defined as spot urine (morning void) calcium-creatinine ratio \> 0.275 within 18 months of screening.
- Baseline serum 25(OH)D level greater than 100 ng/mL. Other
- Participation (within 30 days of screening) in another treatment research study, and unwillingness to refrain from participating in another intervention study during the study.
- Previous randomization in the study. Participants who did not qualify after screening may be screened again if the prior reason for exclusion has been addressed (e.g., high blood pressure is treated).
- Any other reason that in the opinion of the site investigator would interfere with the study objectives, impede adherence with study procedures or hinder completion of the study or increase risk. Women only
- Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 2 years. History of gestational diabetes is not an exclusion criterion.
- Currently breastfeeding.
- Use of oral contraceptives or menopausal hormone therapy started within 3 months of baseline. . Continuous Glucose Monitoring specific
- Regular use of personal CGM and unwillingness to refrain from using personal CGM for the duration of the study.
- Use of hydroxyurea or regular use of high doses of acetaminophen (may impact CGM).
- Extensive skin changes (e.g., skin breakdown, rash) making CGM sensor use problematic.
- Significant skin sensitivity to adhesive (making CGM sensor unfeasible).
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.