| Trial ID: | L3720 |
| Source ID: | NCT01170468
|
| Associated Drug: |
Vitamin D3
|
| Title: |
Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Vitamin D3|DRUG: Placebo
|
| Outcome Measures: |
Primary: The incidence of DM, Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge., 2 years | Secondary: slope of fasting glucose level, 2 years|slope of 2-hour post challenge glucose level, 2 years|area under the curve of BP, 2 years|area under the curve of weight, 2 years|area under the curve of 25 OH vitamin D level, 2 years|fasting insulin to glucose ratio, 2 years|incidence of hypercalcemia, 2 years|incidence of hypercalciuria, 2 years|time to develop DM, Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge., 2 years
|
| Sponsor/Collaborators: |
Sponsor: King Faisal Specialist Hospital & Research Center
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2011-12
|
| Completion Date: |
2014-01-15
|
| Results First Posted: |
|
| Last Update Posted: |
2018-03-07
|
| Locations: |
King Faisal Specialist Hospital & Research Center, Riyadh, 11211, Saudi Arabia
|
| URL: |
https://clinicaltrials.gov/show/NCT01170468
|
