Trial Outcomes & Findings for Vitamin D Effects in Overweight Patients (NCT NCT00493012)

NCT ID: NCT00493012

Last Updated: 2017-04-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: baseline, 12 months
• Results posted on: 2017-04-13

Participant Flow

Participant milestones

Measure	Experiment A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator A daily placebo oil is given for year
Overall Study STARTED	100	100
Overall Study COMPLETED	82	83
Overall Study NOT COMPLETED	18	17

Reasons for withdrawal

Measure	Experiment A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator A daily placebo oil is given for year
Overall Study Lost to Follow-up	18	17

Baseline Characteristics

Vitamin D Effects in Overweight Patients

Baseline characteristics by cohort

Measure	Experiment n=100 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=100 Participants A daily placebo oil is given for year	Total n=200 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	98 Participants n=5 Participants	98 Participants n=7 Participants	196 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	47.4 years STANDARD_DEVIATION 10.3 • n=5 Participants	48.8 years STANDARD_DEVIATION 10.1 • n=7 Participants	48.1 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	72 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	28 Participants n=7 Participants	66 Participants n=5 Participants
Region of Enrollment Germany	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in Body Weight From Baseline to 12 Months	-5.7 kg Standard Deviation 5.8	-6.4 kg Standard Deviation 5.6

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in Fat Mass From Baseline to 12 Months	-4.1 kg Standard Deviation 4.6	-4.9 kg Standard Deviation 4.9

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in 25-hydroxyvitamin D From Baseline to 12 Months	55.5 nmol/l Standard Deviation 55.8	11.8 nmol/l Standard Deviation 36.3

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in Calcitriol From Baseline to 12 Months	40.0 pmol/l Standard Deviation 95.0	9.3 pmol/l Standard Deviation 57.0

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in Parathyroid Hormone From Baseline to 12 Months	-1.24 pmol/l Standard Deviation 2.18	-0.91 pmol/l Standard Deviation 2.55

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in Triglycerides From Baseline to 12 Months	-0.19 mmol/l Standard Deviation 0.54	0.03 mmol/l Standard Deviation 0.50

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in LDL-cholsterol From Baseline to 12 Months	0.19 mmol/l Standard Deviation 1.03	-0.09 mmol/l Standard Deviation 0.17

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in C-reactive Protein From Baseline to 12 Months	-0.03 mg/l Standard Deviation 0.46	-0.05 mg/l Standard Deviation 0.68

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in Tumor Necrosis Factor Alpha From Baseline to 12 Months	-0.80 pg/ml Standard Deviation 2.5	-0.26 pg/ml Standard Deviation 2.9

SECONDARY outcome

Timeframe: baseline, 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in Proinsulin From Baseline to 12 Months	-4.6 pmol/l Standard Deviation 14.9	-4.1 pmol/l Standard Deviation 9.9

SECONDARY outcome

Timeframe: change from baseline to 12 months

Outcome measures

Measure	Experiment n=82 Participants A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.	Placebo Comparator n=83 Participants A daily placebo oil is given for year
Change in Hb A1c From Baseline to 12 Months	-0.25 % glycosylated hemoglobin Standard Deviation 0.23	-0.25 % glycosylated hemoglobin Standard Deviation 0.23

Adverse Events

Experiment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Comparator

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

Dr. Armin Zittermann

Heart and Diabetes Center North Rhine-Westfalia

Phone: +49 5731 97

Email: azittermann@hdz-nrw.de

Results disclosure agreements

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