Printed from Voxsanity (voxsanity.com.au) — NCT07448974 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Type 2 Diabetes Trial, Not Yet Recruiting
NCT07448974
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who have prediabetes classified as "high risk," meaning their fasting blood sugar level falls between 100–125 mg/dL AND their HbA1c (a measure of average blood sugar over time) falls between 5.7–6.4%.
- People aged 30 to 74 years old.
- People whose Body Mass Index (BMI) is between 23.0 and 35.0 kg/m².
- People who have signed and dated a consent form agreeing to take part before any study procedures begin.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have a history of diabetes, or whose blood sugar levels at the screening visit meet the criteria for diabetes (fasting blood sugar of 126 mg/dL or higher, or HbA1c of 6.5% or higher).
- People who have had overactive parathyroid glands, kidney stones (with or without symptoms), or high blood calcium levels in the past 2 years.
- People who have had any medical condition in the past 2 years that, in the trial site investigator's opinion, may increase the risk of developing kidney stones or high blood calcium during the trial (for example, sarcoidosis).
- People over age 70 who have had a fall in the past year.
- People who have used tanning beds or devices within 12 weeks of the baseline visit and are unwilling to stop using them for the duration of the study.
- People who have taken blood sugar-lowering medications (approved by the FDA for type 2 diabetes, whether tablets or injections) in the past 6 months for any reason, or any other medication that may affect blood sugar levels (for example, hydroxychloroquine).
- People who are currently taking FDA-approved weight management medications (such as incretin receptor agonists), or who plan to use them during the study.
- People who have used vitamin D supplements at doses higher than 1,000 IU per day within 8 weeks of the baseline visit, and who are unwilling to keep their vitamin D supplement dose at or below 1,000 IU per day during the study (all supplements would need to be brought to the site for review by the research team).
- People who have used calcium supplements at doses higher than 600 mg per day within 1 week of the baseline visit, and who are unwilling to keep their calcium supplement dose at or below 600 mg per day during the study.
- People who are currently taking medications, or who have conditions (for example, untreated coeliac disease), that would interfere with how the body absorbs or processes vitamin D.
- People who started taking a seizure (anticonvulsant) medication within 6 months of the screening visit (people on a stable, long-term anticonvulsant regimen are not excluded by this criterion).
- People who have had a bad reaction to vitamin D supplements in the past, are allergic to any ingredient in the study drug, or are unwilling to take vitamin D supplements — for example, people following a vegan diet who would object to the cholecalciferol ingredient, which is derived from cholesterol extracted from the wool of healthy living sheep.
- People with serious active heart or cardiovascular symptoms, including unstable chest pain, breathlessness on exertion, episodes of breathlessness at night, irregular heartbeat, heart failure (moderate or severe), or leg pain when walking.
- People who have had a heart attack, a procedure to open blocked heart arteries, or open-heart bypass surgery in the past year.
- People who have had a stroke or a mini-stroke (transient ischaemic attack) in the past year.
- People who have had any type of cancer in the past 5 years, with some exceptions: basal cell skin cancer is not an exclusion; prostate cancer in men over 55, or well-differentiated thyroid cancer not expected to need treatment (other than thyroid hormone) in the next 3 years, are not exclusions; squamous cell skin cancer that was fully removed with no sign of spread is also not an exclusion.
- People who have used steroid tablets or intravenous steroids (for more than 7 days) in the past 6 months, or who have a condition likely to require that treatment during the study (inhaled steroids, epidural or joint injections, and physiologic steroid doses for adrenal insufficiency in otherwise stable patients are not exclusions, though study visits must be at least two weeks after any joint or epidural injection).
- People who have had a substance use problem or an unstable mental health condition in the past year that, in the site investigator's opinion, could affect their ability to safely participate in or complete the study.
- People who have had bariatric (weight loss) surgery (such as gastric bypass or gastric sleeve), or who plan to have it within the next 2 years.
- People who follow extreme intermittent fasting diets involving fasting periods of more than 18 hours, because very long fasting periods affect a key enzyme involved in vitamin D processing.
- People who have had a life-threatening event within 30 days of the screening visit, or who have major surgery planned.
- People with any other active medical condition — including but not limited to liver disease, a wasting illness, HIV, tuberculosis, oxygen-dependent lung disease, organ transplant, or Cushing's syndrome — that in the site investigators' opinion would interfere with the study, affect the ability to safely take part, or increase risk.
- People with uncontrolled high blood pressure (systolic above 160 mmHg or diastolic above 100 mmHg).
- People who have poor vein access (which may make blood draws difficult).
- People whose liver enzyme levels were more than three times the upper limit of normal in the past 18 months, based on the clinical site's laboratory range.
- People who have anaemia (low red blood cell levels), who have received a whole blood transfusion in the past 18 months or require transfusions regularly, who have donated whole blood in the past 3 months, or who have another condition (such as haemolysis or a haemoglobin disorder) that would make HbA1c an unreliable measure of blood sugar levels (people who donate platelets are not excluded by this criterion).
- People whose platelet count was below 100,000 within the past 18 months.
- People with chronic kidney disease, defined as a kidney filtration rate below 50 mL/min per 1.73 m², calculated using a specific standard formula, within the past 18 months.
- People with high blood calcium levels (at or above the upper limit of normal) within the past 18 months.
- People with high calcium levels in their urine, based on a specific urine test result (calcium-to-creatinine ratio above 0.275 on a morning urine sample) within the past 18 months.
- People whose vitamin D level (measured as serum 25(OH)D) is above 100 ng/mL at the start of the study.
- People who have taken part in another interventional research study within 30 days of the screening visit and are unwilling to refrain from joining another intervention study during this trial.
- People who have previously been randomly assigned to a treatment group in this study (people who did not qualify at an earlier screening may be screened again if the earlier reason for exclusion has since been addressed, for example, if blood pressure has been treated and brought under control).
- People who, for any other reason in the site investigator's opinion, would be unable to safely or reliably take part in or complete the study.
- Women who have been pregnant in the past year (by report or positive pregnancy test at screening), or who intend to become pregnant in the next 2 years (a history of gestational diabetes is not an exclusion).
- Women who are currently breastfeeding.
- Women who started using the oral contraceptive pill or menopausal hormone therapy within 3 months of the baseline visit.
- People who regularly use a personal continuous glucose monitor (CGM) and are unwilling to stop using their own device for the duration of the study.
- People who use the medication hydroxyurea, or who regularly take high doses of paracetamol (acetaminophen), as these may affect continuous glucose monitor readings.
- People who have extensive skin changes — such as skin breakdown or rash — that would make wearing a continuous glucose monitor sensor problematic.
- People who have significant skin sensitivity to adhesives, making the use of a continuous glucose monitor sensor unfeasible.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 617-636-3232
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
Tufts Medical Center
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 March 2030
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Time-in-normoglycemia 140; Time-In-Normoglycemia 126
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.