Trial Outcomes & Findings for Effect of Vitamin D Replacement on Insulin Sensitivity (NCT NCT01268111)

NCT ID: NCT01268111

Last Updated: 2015-06-08

Results Overview

Insulin stimulated glucose uptake will be measured by glucose clamp studies

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline and at 8 weeks
• Results posted on: 2015-06-08

Participant Flow

Participant milestones

Measure	Vitamin D ERgocalcifoerol 50,000 units q weekly for 8 weeks	Placebo Matching placebo q weekly for 8 weeks
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Vitamin D Replacement on Insulin Sensitivity

Baseline characteristics by cohort

Measure	Vitamin D n=6 Participants ERgocalcifoerol 50,000 units q weekly for 8 weeks	Placebo n=6 Participants Matching placebo q weekly for 8 weeks	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 3.6 • n=5 Participants	27.8 years STANDARD_DEVIATION 2.6 • n=7 Participants	28.4 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at 8 weeks

Insulin stimulated glucose uptake will be measured by glucose clamp studies

Outcome measures

Measure	Vitamin D n=6 Participants ERgocalcifoerol 50,000 units q weekly for 8 weeks	Placebo n=6 Participants Matching placebo q weekly for 8 weeks
M Value (Insulin Stimulated Glucose Uptake) Baseline	4.1 mg/kg.min Standard Deviation 1.56	5.6 mg/kg.min Standard Deviation 1.48
M Value (Insulin Stimulated Glucose Uptake) 8 weeks	4.7 mg/kg.min Standard Deviation 1.35	5.5 mg/kg.min Standard Deviation 1.68

Adverse Events

Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

A J Vinaya Simha

Mayo Clinic

Phone: 5072664321

Email: simha.aj@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place