A Phase 1 interventional study of Vitamin D3 in Obesity, Endothelial Dysfunction and Vitamin D Deficiency, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Prevention
Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents have a high prevalence of Vitamin D deficiency as well as evidence of endothelial dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with Vitamin D would lead to improvement in endothelial dysfunction.
Subjects had a brief screening visit with one of the study team members. Past medical history, current medications and a brief dietary history was taken. The dietary history was taken to assess calcium intake in a day and was obtained via the validated Short Calcium questionnaire. Blood pressure, heart rate as well as height,weight, waist and hip circumference measurement was obtained by study staff. In addition, a brief physical examination to determine Tanner stage was also completed. This involved examination of both breasts and genitalia for adolescent female and only genitalia in males. A physical activity questionnaire (IPAQ) was also administered by the study staff at this visit. A blood draw of 5 ml to measure plasma 25(OH) D, calcium, phosphorus was obtained as part of the screening visit. For girls who had started menstruating, a urine pregnancy test was also obtained.
After the screening visit eligible subjects had baseline biochemical tests and an endothelial function assessment. Study participants received a pill container with six total pills of vitamin cholecalciferol (D3) (1 pill = 50,000 IU), with directions to take two pills once a month (100,000 IU) at the same time for a period of 3 months. Compliance was assessed at the 3 month visit by counting the number of pills remaining in the container.
At 1 month, the subjects had tests for serum calcium and 25 hydroxy vitamin D levels. A urine test for random calcium to creatinine ratio was also obtained.
At 2 months, the serum calcium, 25 hydroxy vitamin D levels, and calcium to creatinine ratio tests were repeated.
At the end of 3 months, biochemical tests and an endothelial function assessment were repeated. Medical history, questionnaires, and the physical exam were also repeated.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 19 is below the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vitamin D3 supplementation at 100,000 IU once a month for 3 months
Dietary Supplement: Vitamin D3
Vitamin D 3 at 100,000 IU once a month for 3 months
Also known as: Cholecalciferol
Flow Mediated Dilatation (FMD)
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.
Time frame: baseline, 3 months
25-hydroxy Vitamin D (25[OH]D) Levels
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.
Time frame: baseline, 3 months
Total Cholesterol
Total cholesterol levels were measured by an enzymatic colorimetric assay.
Time frame: baseline, 3 months
Triglycerides
Total triglyceride levels were measured by an enzymatic colorimetric assay.
Time frame: baseline, 3 months
Body Mass Index
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.
Time frame: baseline, 3 months
International Physical Activity Questionnaire (IPAQ) Short Form Score
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.
Time frame: baseline, 3 months
Calcium Intake Per Day
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.
Time frame: baseline, 3 months
Serum Parathyroid Hormone (PTH)
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.
Time frame: baseline, 3 months
Fasting Glucose
Plasma glucose was measured by hexokinase enzymatic assay.
Time frame: baseline, 3 months
Fasting Insulin
Serum insulin was measured using commercial electrochemiluminescence immunoassay kits.
Time frame: baseline, 3 months
Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)
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.
Time frame: baseline, 3 months
High Sensitivity C-reactive Protein (Hs-CRP)
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.
Time frame: baseline, 3 months
Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels
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.
Time frame: baseline, 3 months
High Density Lipoprotein (HDL) Cholesterol Levels
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.
Time frame: baseline, 3 months
Urine Calcium to Creatinine Ratio
Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g.
Time frame: baseline, 3 months
Reactive Hyperemia Index (RHI)
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.
Time frame: baseline, 3 months
Subjects were recruited between February 2013 and December 2013 at Mayo Clinic in Rochester, Minnesota.
| Milestone | Vitamin D3 |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
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.
| percentage increase in BAD | Vitamin D3 |
|---|---|
| Baseline FMD | 9.5 ± 3.52 |
| 3 months FMD | 10.4 ± 3.82 |
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.
| nmol/L | Vitamin D3 |
|---|---|
| baseline 25(OH)D | 55.9 ± 12.2 |
| 3 months 25(OH)D | 86.9 ± 16.7 |
Total cholesterol levels were measured by an enzymatic colorimetric assay.
| mmol/L | Vitamin D3 |
|---|---|
| baseline | 3.69 ± 0.71 |
| 3 months | 4.03 ± 0.87 |
Total triglyceride levels were measured by an enzymatic colorimetric assay.
| mmol/L | Vitamin D3 |
|---|---|
| Baseline | 1.19 ± 0.57 |
| 3 months | 1.58 ± 0.81 |
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.
| kg/m^2 | Vitamin D3 |
|---|---|
| baseline | 36.1 ± 6.03 |
| 3 months | 36.4 ± 6.11 |
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.
| MET-minutes per week | Vitamin D3 |
|---|---|
| baseline | 1786.6 ± 1506.2 |
| 3 months | 2799.1 ± 3834.6 |
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.
| mg/day | Vitamin D3 |
|---|---|
| baseline | 1102.7 ± 304.3 |
| 3 months | 975.5 ± 282.2 |
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.
| pmol/L | Vitamin D3 |
|---|---|
| baseline | 4.1 ± 1.6 |
| 3 months | 3.3 ± 1.1 |
Plasma glucose was measured by hexokinase enzymatic assay.
| mmol/L | Vitamin D3 |
|---|---|
| baseline | 4.9 ± 0.28 |
| 3 months | 4.97 ± 0.26 |
Serum insulin was measured using commercial electrochemiluminescence immunoassay kits.
| pmol/L | Vitamin D3 |
|---|---|
| baseline | 225.71 ± 127.93 |
| 3 months | 245.16 ± 150.01 |
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.
| index of beta cell function | Vitamin D3 |
|---|---|
| baseline | 7.11 ± 4.18 |
| 3 months | 7.9 ± 5.1 |
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.
| nmol/L | Vitamin D3 |
|---|---|
| baseline | 47.62 ± 35.43 |
| 3 months | 40 ± 25.7 |
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.
| mmol/L | Vitamin D3 |
|---|---|
| baseline | 1.95 ± 0.66 |
| 3 months | 2.15 ± 0.81 |
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.
| mmol/L | Vitamin D3 |
|---|---|
| baseline | 1.2 ± 0.28 |
| 3 months | 1.16 ± 0.23 |
Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g.
| mg/g | Vitamin D3 |
|---|---|
| baseline | 67.8 ± 59.2 |
| 3 months | 87.7 ± 73.2 |
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.
| percentage increase in blood flow | Vitamin D3 |
|---|---|
| baseline | 449.3 ± 243.5 |
| 3 months | 513.9 ± 325.6 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D3 | — | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Vitamin D3 |
|---|---|
| Mean | 15.8 ± 1.7 |
| Sex: Female, Male(Participants) | Vitamin D3 |
|---|---|
| Female | 7 |
| Male | 12 |
| Region of Enrollment(participants) | Vitamin D3 |
|---|---|
| United States | 19 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic