Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02416193 · ClinicalTrials.gov registry record · Phase 2
Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)
A Phase 2 study, sponsored by Loyola University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT02416193 is a Phase 2 study that was terminated before completion, run by Loyola University. The registered enrollment target is 56 participants.
The verdict
NCT02416193, a Phase 2 study, was terminated before completion, sponsored by Loyola University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to 2.5 times higher in persons with diabetes than the general population. There is evidence that cognitive decline significantly impacts the ability to self-manage diabetes. Strategies to prevent cognitive decline in persons with diabetes has not been well studied. A recent study reported that in persons who had vitamin D deficiency, the risk for all-cause dementia and Alzheimer's was doubled. Vitamin D receptors are located in the brain and deficiency of vitamin D has been reported to negatively affect the development of brain. Therefore, providing vitamin D supplementation to improve cognitive function is worthy of study. The investigators propose a small, randomized controlled trial to determine the effects of vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation (50,000 IUs) or a matching comparator (5000 IUs) for a period of three months. The study aims are to determine (1) the effect of vitamin D3 supplementation on cognitive function and (2) the effect of vitamin D3 supplementation on diabetes self-management. A sample of persons with type 2 diabetes (n=62), who have a subjective complaint of a cognitive dysfunction or scoring at least one standard deviation below normal on a cognitive functioning screening test, have vitamin D levels less 30 ng/ml, are not depressed (as this impacts cognitive function), and do not have severe diabetes complication will be recruited. Participants will be phone screened and complete two baseline visits prior to randomization. They will then have phone call and follow-up visits to assess (1) cognitive function using standardized tests to assess for executive function (2) serum measurements (HBA1c, fasting glucose, vitamin D levels, and cardiometabolic profile) and (3) surveys to assess cognitive function as well as se
Interventions
- DRUG Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-09-23 |
| Est. Completion | 2018-07-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02416193
The ClinicalTrials.gov registry entry for NCT02416193 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loyola University, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cholecalciferol is the first listed.
NCT02416193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02416193 about?
NCT02416193 is a clinical study titled "Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)". Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to 2.5 times higher in persons with diabetes than the general population. There is evidence that cognitive decline significantly impacts the ability to self-manage diabetes. Strategies to prevent cognitive decline...
What is the current status of trial NCT02416193?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2015-09-23. Estimated completion is 2018-07-12.
What interventions are being tested in trial NCT02416193?
The interventions under investigation include: Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT02416193?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.