| Trial ID: | L5996 |
| Source ID: | NCT01904032
|
| Associated Drug: |
Vitamin D3
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| Title: |
Sunshine 2 Study for Women With Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01904032/results
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| Conditions: |
Diabetes|Depression|Quality of Life
|
| Interventions: |
DRUG: Vitamin D3|DRUG: Vitamin D3 comparator
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| Outcome Measures: |
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, 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., Baseline and 6 months | 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, The Problem Areas in Diabetes (PAIDS) score is a self-report questionnaire that assesses diabetes burden and treatment. Scores range from 0 to 100, where higher scores indicate greater distress. For each participant, her baseline PAID score is subtracted from her month 6 PAID score to create a PAID change score., Baseline and 6 months|Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort, Systolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline systolic blood pressure is subtracted from her month 6 systolic blood pressure to create a systolic blood pressure change score., Baseline and 6 months|Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort, Diastolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline diastolic blood pressure is subtracted from her month 6 diastolic blood pressure to create a diastolic blood pressure change score., Baseline and 6 months
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| Sponsor/Collaborators: |
Sponsor: Loyola University | Collaborators: National Institutes of Health (NIH)|National Institute of Nursing Research (NINR)
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| Gender: |
FEMALE
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
265
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2013-11-21
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| Completion Date: |
2018-08-31
|
| Results First Posted: |
2022-03-31
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| Last Update Posted: |
2022-04-26
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| Locations: |
Loyola University Medical Center, Maywood, Illinois, 60153, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01904032
|
