Phase 2
Completed N=129
Sunshine 2 Study for Women With Diabetes
Source: ClinicalTrials.gov NCT01904032 ↗Enrolled (actual)
129
Serious AEs
9.3%
Results posted
Mar 2022
Primary outcomePrimary: Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort — -13.2982; -12.5000 units on a scale — p=.6982
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort |
-13.2982; -12.5000 | .6982 |
| SECONDARY Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort |
-13.2237; -13.2661 | .9908 |
| SECONDARY Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort |
-2.1579; -1.6613 | .8749 |
| SECONDARY Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort |
-0.7544; 0.7581 | .4187 |
Eligibility Criteria
Inclusion Criteria
- Women age 21 and older
- Objective evidence of depressive symptoms at the screening and baseline visits
- Diagnosis of type 2 diabetes currently being treated by a healthcare provider
- Blood vitamin D level less than 32 nanograms-per-deciliter (32 ng/dl)
Exclusion Criteria
- Current alcohol or substance use disorder
- Any unstable or severe psychiatric disease including diagnoses of schizophrenia, bipolar affective disorder, dementia, delirium, or other psychotic disorder
- Severe complications of diabetes, such as blindness and/or amputation
- Any malabsorption disorder, such as Crohn's disease and/or celiac sprue
- Elevated serum calcium level deemed significant by the Principal Investigator
- Use of 1, 000 or more international units daily vitamin D 60 days before enrollment and unwillingness to discontinue vitamin D supplementation 30 days before enrollment.
- Use of St. John's Wort and unwillingness to discontinue St. John's Wort three weeks prior to enrollment.
- Participants who are pregnant, nursing, or planning to become pregnant during the study.
- Baseline systolic blood pressure (SBP) greater than 160 millimeters of mercury (mmHG) or diastolic blood pressure (DBP) greater than 100 mmHG.
- Other serious medical conditions (e.g., cancer, multiple sclerosis, etc.) deemed clinically significant by the Principal Investigator
Data sourced from ClinicalTrials.gov (NCT01904032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.