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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR024150 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| Thrasher Research Fund | OTHER |
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The prevalence of obesity has reached epidemic proportions nationally as well as internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to vitamin D insufficient. In adults, low vitamin D status appears to be associated with the development of type 2 diabetes and metabolic syndrome. There is little information on the prevalence of vitamin D insufficiency and its implications in obese adolescents. Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents might result in improvement in insulin resistance, lipids and cardiovascular risk markers.
We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves insulin resistance and cardiovascular risk factors in this population. The purpose of the study is to determine the impact of vitamin D3 supplementation on various parameters of insulin secretion, insulin action, lipids and C-reactive protein in obese adolescents.
The problem of childhood obesity has reached epidemic proportions both nationally and internationally. The prevalence of obesity has tripled in the last three decades and currently 16 % of American adolescents are obese. Nearly 30% of obese adolescents demonstrate a metabolic syndrome characterized by insulin resistance and dyslipidemia. These abnormalities lead to the development of type 2 diabetes mellitus and to increased cardiovascular morbidity and mortality. Obesity is a well-known risk factor for vitamin D insufficiency and up to 80% of obese adults have been found to be insufficient in vitamin D. Observational studies in adults have shown consistent associations between low vitamin D status and prevalence of type 2 diabetes mellitus and metabolic syndrome. There is paucity of data on the prevalence of vitamin D insufficiency and its implications in obese adolescents. It is also not known whether treatment of vitamin D insufficiency in children or adults might result in improvement in insulin resistance and cardiovascular risk factors.
Hypotheses: We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation decreases insulin resistance and cardiovascular risk factors in this population.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3-low dose | Experimental | Vitamin D3 400 IU capsule, one capsule daily for 12 weeks. |
|
| Vitamin D3-high dose | Experimental | Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation | Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia. From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation | Less than 200 mg/dL is desirable, >200 mg/dL is borderline high, >240 mg/dL is High | baseline, 12 weeks |
| Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with 25 (OH)- D levels >100 ng/mL
Serum calcium >10.8 mg/dL
Current cancer
Those taking a multivitamin supplementation
Hepatic or renal disorders
Type 1 or type 2 diabetes mellitus.
Those receiving insulin, metformin or oral hypoglycemic medications
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| Name | Affiliation | Role |
|---|---|---|
| Seema Kumar, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25644349 | Derived | Javed A, Vella A, Balagopal PB, Fischer PR, Weaver AL, Piccinini F, Dalla Man C, Cobelli C, Giesler PD, Laugen JM, Kumar S. Cholecalciferol supplementation does not influence beta-cell function and insulin action in obese adolescents: a prospective double-blind randomized trial. J Nutr. 2015 Feb;145(2):284-90. doi: 10.3945/jn.114.202010. Epub 2014 Dec 17. |
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Participants were enrolled at the Mayo Clinic in Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3-low Dose | Vitamin D3 400 IU capsule, one capsule daily Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks. |
| FG001 | Vitamin D3-high Dose | Vitamin D3 2000 IU capsule, one capsule daily Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
|
| |||||||||||||||||||||
| Week 12 Follow-up |
|
47 Subjects started the study, but one subject in the Vitamin D3-high dose arm only completed one visit. The baseline characteristics are reported on the 47 subjects who started the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3-low Dose | Vitamin D3 400 IU capsule, one capsule daily |
| BG001 | Vitamin D3-high Dose | Vitamin D3 2000 IU capsule, one capsule daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation | Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia. From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance. | All subjects had blood drawn but some tests such as insulin could not be done in some cases due to sample issues. This lab test was calculated from other parameters and not drawn per se. If the values obtained did not allow a calculation of the lab test, then the results could not be reported. | Posted | Mean | Standard Deviation | HOMA score | Baseline, 12 weeks |
|
Adverse events were collected over the duration of the study, an average of 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D3-low Dose | Vitamin D3 400 IU capsule, one capsule daily for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheaded and dizzy | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seema Kumar, MD | Mayo Clinic | 507-284-3300 | kumar.seema@mayo.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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LDL cholesterol is considered to be the main source of cholesterol buildup and blockage in the arteries. Less than 100 mg/dL is optimal, >130 mg/dL is borderline high, >160 mg/dL is high, >190 mg/dL is very high. |
| baseline, 12 weeks |
| Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation | HDL (good) cholesterol protects against heart disease, so for HDL, higher numbers are better. A level less than 40 mg/dL is low and is considered a major risk factor because it increases your risk for developing heart disease. HDL levels of 60 mg/dL or more help to lower your risk for heart disease. | baseline, 12 weeks |
| Change in Triglycerides After 12 Weeks of Vitamin D Supplementation | The current recommendation on fasting blood triglyceride levels: < 150 mg/dL is normal, >150 mg/dL is borderline high, and >200 mg/dL is high. | baseline, 12 weeks |
| Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation | The high-sensitivity C-reactive protein test measures your risk for heart problems. <1.0 mg/L is lowest risk, 1.0-3.0 mg/L is average risk, and >3.0 mg/L is highest risk. | baseline, 12 weeks |
| Protocol Violation |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Vitamin D3-low Dose | Vitamin D3 400 IU capsule, one capsule daily for 12 weeks. |
| OG001 | Vitamin D3-high Dose | Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks. |
|
|
|
| Secondary | Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation | Less than 200 mg/dL is desirable, >200 mg/dL is borderline high, >240 mg/dL is High | One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24. | Posted | Mean | Standard Deviation | mg/dL | baseline, 12 weeks |
|
|
|
|
| Secondary | Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation | LDL cholesterol is considered to be the main source of cholesterol buildup and blockage in the arteries. Less than 100 mg/dL is optimal, >130 mg/dL is borderline high, >160 mg/dL is high, >190 mg/dL is very high. | One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24. | Posted | Mean | Standard Deviation | mg/dL | baseline, 12 weeks |
|
|
|
|
| Secondary | Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation | HDL (good) cholesterol protects against heart disease, so for HDL, higher numbers are better. A level less than 40 mg/dL is low and is considered a major risk factor because it increases your risk for developing heart disease. HDL levels of 60 mg/dL or more help to lower your risk for heart disease. | One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24. | Posted | Mean | Standard Deviation | mg/dL | baseline, 12 weeks |
|
|
|
|
| Secondary | Change in Triglycerides After 12 Weeks of Vitamin D Supplementation | The current recommendation on fasting blood triglyceride levels: < 150 mg/dL is normal, >150 mg/dL is borderline high, and >200 mg/dL is high. | One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24. | Posted | Mean | Standard Deviation | mg/dL | baseline, 12 weeks |
|
|
|
|
| Secondary | Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation | The high-sensitivity C-reactive protein test measures your risk for heart problems. <1.0 mg/L is lowest risk, 1.0-3.0 mg/L is average risk, and >3.0 mg/L is highest risk. | One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24. | Posted | Mean | Standard Deviation | mg/L | baseline, 12 weeks |
|
|
|
|
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | Vitamin D3-high Dose | Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks. | 0 | 24 | 0 | 24 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |