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| ID | Type | Description | Link |
|---|---|---|---|
| 18885 | Other Identifier | Stanford IRB |
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Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher.
Vitamin D is essential for the body to maintain normal calcium levels and strong bones. Recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin D plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat.
The purpose of this study is to determine the effect of vitamin D supplementation on inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin D stores and inflammatory cytokines.
In an observed, randomized controlled trial over 6 months we will provide observed vitamin D supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that administration of vitamin D to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).
Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum 25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese youth. Further studies are needed to establish the dose of vitamin D required to increase 25OHD and determine potential effects on metabolic risk factors in obese teens.
During the course of the study, blood pressure removed from the prespecified outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D | Experimental | Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks |
|
| Placebo | Placebo Comparator | Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drisdol (Ergocalciferol) Vitamin D2 | Drug | Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 25OH Vitamin D | Primary outcome is serum 25OH vitamin D concentrations | Baseline; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides at Baseline and Week 24 | Baseline; Week 24 | |
| High-density Lipoprotein (HDL) at Baseline and Week 24 | Baseline; Week 24 | |
| Hemoglobin A1C (HgbA1c) at Baseline and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who currently receive:
Patients who currently have or history of:
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| Name | Affiliation | Role |
|---|---|---|
| Laura K Bachrach | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25873553 | Result | Shah S, Wilson DM, Bachrach LK. Large Doses of Vitamin D Fail to Increase 25-Hydroxyvitamin D Levels or to Alter Cardiovascular Risk Factors in Obese Adolescents: A Pilot Study. J Adolesc Health. 2015 Jul;57(1):19-23. doi: 10.1016/j.jadohealth.2015.02.006. Epub 2015 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks. |
| FG001 | Placebo | Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 25OH Vitamin D | Primary outcome is serum 25OH vitamin D concentrations | Patients who completed the study were analyzed. | Posted | Mean | Standard Error | ng/mL | Baseline; Week 24 |
|
24 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 D | Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sejal Shah MD | Stanford University | 6507211811 | sshah2@stanford.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Placebo pill - 3 pills every 12 weeks for total of 24 weeks |
|
HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months. |
| Baseline; Week 24 |
| Interleukin-6 (IL-6) at Baseline and Week 24 | Baseline; Week 24 |
| Interleukin-10 (IL-10) at Baseline and Week 24 | Baseline; Week 24 |
| Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24 | Baseline; Week 24 |
| C-reactive Protein (CRP) at Baseline and Week 24 | Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test. | Baseline; Week 24 |
| Adiponectin at Baseline and Week 24 | Baseline; Week 24 |
| BG001 | Placebo | Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| 25OH vitamin D | Mean | Full Range | ng/mL |
|
Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks |
|
|
| Secondary | Triglycerides at Baseline and Week 24 | Patients who completed the study were analyzed. | Posted | Mean | Standard Error | mg/dL | Baseline; Week 24 |
|
|
|
| Secondary | High-density Lipoprotein (HDL) at Baseline and Week 24 | Patients who completed the study were analyzed. | Posted | Mean | Standard Error | mg/dL | Baseline; Week 24 |
|
|
|
| Secondary | Hemoglobin A1C (HgbA1c) at Baseline and Week 24 | HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months. | Patients who completed the study were analyzed. | Posted | Mean | Standard Error | Percentage of glycosylated hemoglobin | Baseline; Week 24 |
|
|
|
| Secondary | Interleukin-6 (IL-6) at Baseline and Week 24 | Patients who completed the study were analyzed. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline; Week 24 |
|
|
|
| Secondary | Interleukin-10 (IL-10) at Baseline and Week 24 | Patients who completed the study were analyzed. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline; Week 24 |
|
|
|
| Secondary | Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24 | Patients who completed the study were analyzed. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline; Week 24 |
|
|
|
| Secondary | C-reactive Protein (CRP) at Baseline and Week 24 | Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test. | Patients who completed the study were analyzed. | Posted | Mean | Standard Error | mg/L | Baseline; Week 24 |
|
|
|
| Secondary | Adiponectin at Baseline and Week 24 | Patients who completed the study were analyzed. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline; Week 24 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks | 0 | 20 | 1 | 20 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |