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NCT01904032 · ClinicalTrials.gov registry record · Phase 2
Sunshine 2 Study for Women With Diabetes
A Phase 2 study of Depression and Diabetes, sponsored by Loyola University.
- Completed
- Registry status
- Phase 2
- Development phase
- 265
- Enrollment target
- 1
- Study location
NCT01904032: Completed Phase 2 study of Depression and Diabetes, sponsored by Loyola University.
NCT01904032 is a Phase 2 study of Depression and Diabetes that has completed, run by Loyola University. The registered enrollment target is 265 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904032, a Phase 2 study of Depression and Diabetes, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 265 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3 supplementation on depressive symptoms, self-management, and blood pressure in approximately 180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting adult women who are eligible to participate will be randomly assigned to either a weekly dose of 50,000 international units of vitamin D3 supplementation or a matching weekly active comparator of 5,000 international units of vitamin D3 for six months. Participants will complete approximately four in-person study visits and several telephone visits throughout the six month trial period, where the researchers will assess depressive symptoms, diabetes self-management, and systolic blood pressure.
Primary Outcome
The Center for Epidemiologic Studies Depression (CES-D) is a self-report questionnaire assessing frequency and severity of depression symptoms. Raw scores range from 0 to 60, where higher scores indicate worse mood. For each participant, her baseline CES-D score is subtracted from her month 6 CES-D score to create a CES-D change score.
Conditions Studied
Interventions
- DRUG Vitamin D3
- DRUG Vitamin D3 comparator
Study Locations (1)
Illinois
- Loyola University Medical Center - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2013-11-21 |
| Est. Completion | 2018-08-31 |
| Phase | Phase 2 |
What the finished NCT01904032 record still lists
NCT01904032 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (66% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Vitamin D3 is the first listed.
NCT01904032 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01904032 about?
NCT01904032 is a clinical study titled "Sunshine 2 Study for Women With Diabetes". This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3 supplementation on depressive symptoms, self-management, and blood pressure in approximately 180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting adult women who are eligible t...
What is the current status of trial NCT01904032?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2013-11-21. Estimated completion is 2018-08-31.
What conditions does trial NCT01904032 study?
This clinical trial studies the following conditions: Depression, Diabetes, Quality of Life.
What interventions are being tested in trial NCT01904032?
The interventions under investigation include: Vitamin D3 (DRUG), Vitamin D3 comparator (DRUG).
Who is sponsoring clinical trial NCT01904032?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01904032 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01904032's enrollment target sits among peer trials
265 167th of 679 higher than 513 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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