About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vitamin D (Cholecalciferol )
- Placebo
Treatment groups
Sponsors and collaborators
Tufts Medical Center
Lead sponsor
Abiogen Pharma
Collaborator