Vitamin D for Prediabetes

(D2d-TTT Trial)

Overseen By Tufts Medical Center Endocrine Research Team

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tufts Medical Center

Must not be taking: Hypoglycemics, Weight management drugs

Disqualifiers: Diabetes, Hyperparathyroidism, Cardiovascular disease, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that vitamin D is generally safe and well-tolerated. Studies have found that a high dose of vitamin D (4,000 IU per day) was safe for individuals who are overweight or obese and at high risk for diabetes. Even at higher doses, vitamin D did not cause major side effects in these groups. The evidence suggests that vitamin D is unlikely to cause harm when used in a clinical trial for prediabetes. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Inclusion Criteria

Provision of signed and dated written informed consent prior to any study procedures

Body Mass Index between 23.0 and 35.0 kg/m2

High-risk prediabetes defined by meeting specific criteria established by the American Diabetes Association

Exclusion Criteria

I have a condition that raises my risk for kidney stones or high calcium levels.

I have had high calcium, kidney stones, or hyperparathyroidism in the past 2 years.

Previous randomization in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly vitamin D supplements or placebo, with dose adjustments after 3 months based on blood tests

18 months

Scheduled study visits, periodic phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vitamin D (Cholecalciferol)

How Is the Trial Designed?

Group I: Vitamin D Active Control 1 Intervention

Participants will receive oral vitamin D (cholecalciferol) once weekly throughout the study.

Group II: Placebo Placebo Group 1 Intervention

Participants in this arm will receive an oral placebo taken once weekly throughout the study.

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Abiogen Pharma

Industry Sponsor

Trials

3

Recruited

90+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36745886/

Vitamin D and Risk for Type 2 Diabetes in People With ...

Vitamin D reduced risk for diabetes by 15% (hazard ratio, 0.85 [95% CI, 0.75 to 0.96]) in adjusted analyses, with a 3-year absolute risk reduction of 3.3%.

2.

nature.com

nature.com/articles/s41430-022-01068-8

Safety and tolerability of high-dose daily vitamin D 3 ...

Vitamin D 3 supplementation at 4000 IU per day was safe and well tolerated among overweight/obese participants at high risk for diabetes.

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1900906

Vitamin D Supplementation and Prevention of Type 2 ...

We powered our trial to detect a 25% lower risk of diabetes with vitamin D than with placebo. On the basis of the results from all three trials, vitamin D ...

4.

ajmc.com

ajmc.com/view/vitamin-d-linked-to-reduced-diabetes-risk-in-adults-with-prediabetes

Vitamin D Linked to Reduced Diabetes Risk in Adults With ...

Adjusted analyses showed vitamin D reduced diabetes risk by 15%, with a 3-year absolute risk reduction of 3.3%.

5.

consultqd.clevelandclinic.org

consultqd.clevelandclinic.org/vitamin-d3-supplementation-fails-to-significantly-lower-diabetes-risk-in-patients-with-pre-diabetes

Vitamin D3 Supplementation Fails to Significantly Lower ...

Supplementing with vitamin D3 has no significant clinical impact on diabetes prevention, according to a randomized clinical trial published ...