| Trial ID: | L1009 |
| Source ID: | NCT00892099
|
| Associated Drug: |
Ergocalciferol
|
| Title: |
DIVINE: Dialysis Infection and Vitamin D In New England
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00892099/results
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: Ergocalciferol|DRUG: Ergocalciferol|OTHER: Placebo
|
| Outcome Measures: |
Primary: Serum 25D Level, 12 weeks | Secondary: Serum Calcium, serum calcium levels (mg/dL), every 4 weeks for 12 weeks|Serum Phosphate, serum phosphate levels (mmol/L), every 4 weeks for 12 weeks|Serum 25-OH Vitamin D, serum 25-OH vitamin D levels (ng/mL), every 4 weeks for 12 weeks|Serum 1,25(OH)2 Levels, serum 1,25(OH) vitamin D levels (pg/mL), At week 12|Parathyroid Hormone, serum PTH levels (pg/mL), every 4 weeks for 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Massachusetts General Hospital | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
105
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2009-11
|
| Completion Date: |
2014-10
|
| Results First Posted: |
2015-06-08
|
| Last Update Posted: |
2018-04-20
|
| Locations: |
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00892099
|
