Trial Outcomes & Findings for Vitamin D in Minorities With Prediabetes (NCT NCT00876928)

NCT ID: NCT00876928

Last Updated: 2013-06-14

Results Overview

Diabetes defined by a FPG\>=126 mg/dl or a 2-hr glucose concentration on an OGTT of \>=200 mg/dl

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 117 participants
• Primary outcome timeframe: one year
• Results posted on: 2013-06-14

Participant Flow

Participant milestones

Measure	Placebo Subjects with low vitamin D levels and pre-diabetes Medium chain triglyceride given once per week	Vitamin D Subjects with low vitamin D levels and pre-diabetes Liquid vitamin D3 dissolved in medium chain triglyceride once per week
Overall Study STARTED	56	61
Overall Study COMPLETED	53	56
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Placebo Subjects with low vitamin D levels and pre-diabetes Medium chain triglyceride given once per week	Vitamin D Subjects with low vitamin D levels and pre-diabetes Liquid vitamin D3 dissolved in medium chain triglyceride once per week
Overall Study Lost to Follow-up	2	5
Overall Study Hypokalemia-affects insulin secretion	1	0

Baseline Characteristics

Vitamin D in Minorities With Prediabetes

Baseline characteristics by cohort

Measure	Placebo n=56 Participants Subjects with low vitamin D levels and pre-diabetes	Vitamin D n=61 Participants Subjects with low vitamin D levels and pre-diabetes	Total n=117 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	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age Continuous	52.5 Years STANDARD_DEVIATION 7.0 • n=5 Participants	52.3 Years STANDARD_DEVIATION 8.0 • n=7 Participants	52.4 Years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	43 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants	61 participants n=7 Participants	117 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: Minorities with pre-diabetes and hypovitaminosis D

Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl

Outcome measures

Measure	Placebo n=53 Participants Subjects with low vitamin D levels and pre-diabetes	Vitamin D n=56 Participants Subjects with low vitamin D levels and pre-diabetes
Percent of Subjects Who Develop Diabetes	9 percentage of participants	12 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9, 12 months

Population: modified intent to treat

Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better

Outcome measures

Measure	Placebo n=53 Participants Subjects with low vitamin D levels and pre-diabetes	Vitamin D n=56 Participants Subjects with low vitamin D levels and pre-diabetes
Disposition Index Disposition Index at 9 months	1.3 Unitless Standard Deviation 0.6	1.3 Unitless Standard Deviation 0.4
Disposition Index Dispostion Index at baseline	1.4 Unitless Standard Deviation 0.5 • Interval 1.3 to 1.6	1.3 Unitless Standard Deviation 0.4 • Interval 1.2 to 1.3
Disposition Index Disposition Index at 3 months	1.5 Unitless Standard Deviation 0.8	1.3 Unitless Standard Deviation 0.5
Disposition Index Disposition Index at 6 months	1.4 Unitless Standard Deviation 0.6	1.2 Unitless Standard Deviation 0.5
Disposition Index Disposition Index at 12 months	1.6 Unitless Standard Deviation 1.6	1.3 Unitless Standard Deviation 0.5

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D

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

Mayer B. Davidson, MD

Charles R. Drew University

Phone: 323 357-3439

Email: mayerdavidson@cdrewu.edu

Results disclosure agreements

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