Trial Outcomes & Findings for Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents (NCT NCT01746264)

Results Overview

Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery. FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

19 participants

Primary outcome timeframe

baseline, 3 months

Results posted on

2016-05-02

Participant Flow

Subjects were recruited between February 2013 and December 2013 at Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	Vitamin D3 Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Age, Continuous	15.8 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3 months

Population: Data for one subject could not be included as the data on FMD was lost in the system and could not be retrieved.

Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery. FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=18 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Flow Mediated Dilatation (FMD) Baseline FMD	9.5 percentage increase in BAD Standard Deviation 3.52
Flow Mediated Dilatation (FMD) 3 months FMD	10.4 percentage increase in BAD Standard Deviation 3.82

SECONDARY outcome

Timeframe: baseline, 3 months

25(OH)D was measured using liquid chromatography-tandem mass spectrometry. Total 25(OH)D concentrations of each sample was calculated using internal standard, 25(OH)D\_2 and 25(OH)D\_3.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
25-hydroxy Vitamin D (25[OH]D) Levels 3 months 25(OH)D	86.9 nmol/L Standard Deviation 16.7
25-hydroxy Vitamin D (25[OH]D) Levels baseline 25(OH)D	55.9 nmol/L Standard Deviation 12.2

SECONDARY outcome

Timeframe: baseline, 3 months

Total cholesterol levels were measured by an enzymatic colorimetric assay.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Total Cholesterol baseline	3.69 mmol/L Standard Deviation 0.71
Total Cholesterol 3 months	4.03 mmol/L Standard Deviation 0.87

SECONDARY outcome

Timeframe: baseline, 3 months

Total triglyceride levels were measured by an enzymatic colorimetric assay.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Triglycerides 3 months	1.58 mmol/L Standard Deviation 0.81
Triglycerides Baseline	1.19 mmol/L Standard Deviation 0.57

SECONDARY outcome

Timeframe: baseline, 3 months

Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Body Mass Index baseline	36.1 kg/m^2 Standard Deviation 6.03
Body Mass Index 3 months	36.4 kg/m^2 Standard Deviation 6.11

SECONDARY outcome

Timeframe: baseline, 3 months

The IPAQ short form used asked 7 questions about activities in the last 7 days, covering vigorous physical activities, moderate activities, walking, and sitting, asking for days per week, hours per day or minutes per day. The score is reported in metabolic equivalent (MET)-minutes per week. Possible scores could range from 0 (inactive) to greater than 3000 MET-minutes/week (highly active). The definition of high activity was vigorous intensity activity on at least 3 days achieving a minimum total activity of at least 1500 MET-minutes/week OR 7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum total physical activity of at least 3000 MET-minutes/week. Therefore a score of \> 3000 MET-minutes/week was possible.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
International Physical Activity Questionnaire (IPAQ) Short Form Score baseline	1786.6 MET-minutes per week Standard Deviation 1506.2
International Physical Activity Questionnaire (IPAQ) Short Form Score 3 months	2799.1 MET-minutes per week Standard Deviation 3834.6

SECONDARY outcome

Timeframe: baseline, 3 months

Calcium intake was measured using the validated Short Calcium Questionnaire (SCQ). This questionnaire is in the form of an spreadsheet, and asks the participant to enter the number of servings per week of various food items and vitamin or mineral supplements. The spreadsheet calculates the daily calcium intake (mg/day) from the data entered.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Calcium Intake Per Day baseline	1102.7 mg/day Standard Deviation 304.3
Calcium Intake Per Day 3 months	975.5 mg/day Standard Deviation 282.2

SECONDARY outcome

Timeframe: baseline, 3 months

A parathyroid hormone (PTH) blood test measures the level of parathyroid hormone in the blood. This test is used to help identify hyperparathyroidism, to find the cause of abnormal calcium levels, or to check the status of chronic kidney disease. PTH controls calcium and phosphorus levels in the blood. PTH was measured by a two-site chemiluminescent immunometric assay.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Serum Parathyroid Hormone (PTH) baseline	4.1 pmol/L Standard Deviation 1.6
Serum Parathyroid Hormone (PTH) 3 months	3.3 pmol/L Standard Deviation 1.1

SECONDARY outcome

Timeframe: baseline, 3 months

Plasma glucose was measured by hexokinase enzymatic assay.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Fasting Glucose baseline	4.9 mmol/L Standard Deviation 0.28
Fasting Glucose 3 months	4.97 mmol/L Standard Deviation 0.26

SECONDARY outcome

Timeframe: baseline, 3 months

Serum insulin was measured using commercial electrochemiluminescence immunoassay kits.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Fasting Insulin baseline	225.71 pmol/L Standard Deviation 127.93
Fasting Insulin 3 months	245.16 pmol/L Standard Deviation 150.01

SECONDARY outcome

Timeframe: baseline, 3 months

This calculation measures insulin resistance, and requires U.S. standard units. The healthy range is 0.5 to 1.4. Less than 1.0 means the subject is insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. The HOMA-IR was calculated as: HOMA-IR = fasting serum glucose (mmol/L) x fasting insulin (mU/mL)/22.5.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR) baseline	7.11 index of beta cell function Standard Deviation 4.18
Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR) 3 months	7.9 index of beta cell function Standard Deviation 5.1

SECONDARY outcome

Timeframe: baseline, 3 months

A high-sensitivity C-reactive protein (hs-CRP) test may be used to help evaluate an individual for risk of cardiovascular disease (CVD). C-reactive protein (CRP) is a protein that increases in the blood with inflammation. Studies have suggested that a persistent low level of inflammation plays a major role in atherosclerosis, the narrowing of blood vessels due to build-up of cholesterol and other lipids, which is often associated with CVD. The hs-CRP test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation and thus helps predict a person's risk of developing CVD. hs-CRP was measured using particle-enhanced immunonephelometry.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
High Sensitivity C-reactive Protein (Hs-CRP) baseline	47.62 nmol/L Standard Deviation 35.43
High Sensitivity C-reactive Protein (Hs-CRP) 3 months	40 nmol/L Standard Deviation 25.7

SECONDARY outcome

Timeframe: baseline, 3 months

The test for low-density lipoprotein cholesterol is used as part of a lipid profile to predict an individual's risk of developing heart disease. A desirable level is \<3.36 mmol/L; borderline high is 3.36 - 4.11 mmol/L; high is \>/= 4.14 mmol/L. LDL cholesterol was calculated as: LDL = Total cholesterol - HDL cholesterol - Triglycerides/5.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels baseline	1.95 mmol/L Standard Deviation 0.66
Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels 3 months	2.15 mmol/L Standard Deviation 0.81

SECONDARY outcome

Timeframe: baseline, 3 months

Total HDL cholesterol levels were measured by an enzymatic colorimetric assay. The test for high-density lipoprotein cholesterol (HDL-C) is used along with other lipid tests to screen for unhealthy levels of lipids and to determine the risk of developing heart disease. If a subject has a negative risk factor, a desirable HDL level would be \>/= 1.55 mmol/L.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
High Density Lipoprotein (HDL) Cholesterol Levels baseline	1.2 mmol/L Standard Deviation 0.28
High Density Lipoprotein (HDL) Cholesterol Levels 3 months	1.16 mmol/L Standard Deviation 0.23

SECONDARY outcome

Timeframe: baseline, 3 months

Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=19 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Urine Calcium to Creatinine Ratio baseline	67.8 mg/g Standard Deviation 59.2
Urine Calcium to Creatinine Ratio 3 months	87.7 mg/g Standard Deviation 73.2

SECONDARY outcome

Timeframe: baseline, 3 months

Population: Data for one subject could not be included as the data on RHI was lost in the system and could not be retrieved.

The cuff of a sphygmomanometer was placed on the forearm and inflated to 50 mm Hg above the participant's systolic blood pressure for a period of 5 min. The increase in resting brachial blood flow was calculated as the maximum flow recorded in the first 15 seconds after cuff deflation and expressed as a percentage increase from baseline reactive. Higher values are considered normal or improved endothelial function.

Outcome measures

Outcome measures
Measure	Vitamin D3 n=18 Participants Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
Reactive Hyperemia Index (RHI) baseline	449.3 percentage increase in blood flow Standard Deviation 243.5
Reactive Hyperemia Index (RHI) 3 months	513.9 percentage increase in blood flow Standard Deviation 325.6

Adverse Events

Vitamin D3

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. Seema Kumar

Mayo Clinic

Phone: 507-538-2724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place