Vitamin D and Type 2 Diabetes - Treat-To-Target

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT07448974
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Prediabetes
  • Type 2 Diabetes (T2DM)

Eligibility Criteria

Sex
ALL
Age
30 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Vitamin D (Cholecalciferol ) — DRUG
    Vitamin D (cholecalciferol) will be administered orally once weekly for approximately 18 months. The vitamin D will be provided in liquid form in an ampule. Participants in the intervention group will begin with a dose of 25,000 IU per week. A blood vitamin D level will be measured at 3 months, and the dose will be increased to 50,000 IU per week for participants whose results are below the study target.
  • Placebo — DRUG
    Placebo will be administered orally once weekly for approximately 18 months. The placebo will be provided in an ampule and will be matched in appearance, dosing schedule, and duration to the active study medication.

Study Details

This study tests whether taking a weekly dose of vitamin D, with the dose adjusted to reach a target blood vitamin D level, can help control blood sugar levels in adults at high risk of developing type 2 diabetes (prediabetes). Research suggests that vitamin D may play a role in blood sugar control. The goal of this study is to see whether adjusting the dose of vitamin D to reach a specific blood vitamin D level improves blood sugar control compared with a placebo (a look-alike pill without vitamin D). One hundred adults aged 30 to 74 with prediabetes will take part. Participants will be randomly assigned (by chance) to receive either weekly vitamin D supplements or a placebo. Neither the participants nor the research team will know which group a participant is in during the study. Participants in the vitamin D group will start with one specific dose. After three months, a blood test will be used to decide whether the dose should stay the same or be increased to reach the target vitamin D level. Participants in the placebo group will continue taking the placebo each week. All participants will be followed for about 18 months. During the study, they will attend scheduled study visits, have blood tests, and wear a continuous glucose monitor, a small device that measures blood sugar levels throughout the day and night. The research team will also make periodic phone calls to check on health changes, medication use, and study participation. The main outcome of the study is the proportion of time that the participants' blood sugar levels remains in a healthy range.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Vitamin D
    Participants will receive oral vitamin D (cholecalciferol) once weekly throughout the study.
  • Placebo Comparator: Placebo
    Participants in this arm will receive an oral placebo taken once weekly throughout the study.

Primary Outcome Measure

Time-in-normoglycemia 140 [ Time Frame: Assessed every 6 months from enrollment to the end of the study at 18 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Tufts Medical Center Endocrine Research Team
[email protected]
617-636-3232
Anastassios Pittas, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Tufts Medical Center· Boston, MA

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