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Children and adolescents with psychiatric illnesses who are treated with medications called second generation antipsychotic agents (SGA) often gain excessive weight during their treatment with these medications. This weight gain may result in the development of features of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way to prevent these complications. The investigators' hypothesis is that daily vitamin D supplementation in these patients will result in decreased levels of the markers of metabolic syndrome with associated reduction in waist circumference.
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergocalciferols | Drug | 2000 international units by mouth daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment | HOMA-IR: It is calculated multiplying fasting plasma insulin (FPI) by fasting plasma glucose (FPG), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5 | Baseline and 8 weeks |
| Changes in Serum Levels of C-reactive Protein. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin U Nwosu, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Weight | Posted | Mean | Standard Deviation | kilograms | Baseline and 8 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 | This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin U Nwosu, MD | University of Massachusetts Medical School | 5083347872 | benjamin.nwosu@umassmemorial.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D014808 | Vitamin D Deficiency |
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| 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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| Baseline and 8 weeks |
| HDL-cholesterol at Baseline and Post-treatment | Baseline and 8 weeks |
| LDL-cholesterol at Baseline and Post-treatment | Baseline and 8 weeks |
| Total Cholesterol at Baseline and Post-treatment | Baseline and 8 weeks |
| Triglycerides at Baseline and Post-treatment | Baseline and 8 weeks |
| Adiponectin at Baseline and Post-treatment | Baseline and 8 weeks |
| Leptin at Baseline and Post-treatment | Baseline and 8 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment | HOMA-IR: It is calculated multiplying fasting plasma insulin (FPI) by fasting plasma glucose (FPG), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5 | Posted | Mean | Standard Deviation | HOMA-IR score | Baseline and 8 weeks |
|
|
|
| Secondary | Changes in Serum Levels of C-reactive Protein. | Data were not collected for this analyte. | Posted | Baseline and 8 weeks |
|
|
| Secondary | HDL-cholesterol at Baseline and Post-treatment | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8 weeks |
|
|
|
| Secondary | LDL-cholesterol at Baseline and Post-treatment | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8 weeks |
|
|
|
| Secondary | Total Cholesterol at Baseline and Post-treatment | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8 weeks |
|
|
|
| Secondary | Triglycerides at Baseline and Post-treatment | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8 weeks |
|
|
|
| Secondary | Adiponectin at Baseline and Post-treatment | Posted | Mean | Standard Deviation | mcg/mL | Baseline and 8 weeks |
|
|
|
| Secondary | Leptin at Baseline and Post-treatment | Posted | Mean | Standard Deviation | ng/mL | Baseline and 8 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |