An interventional study of Ergocalciferols in Obesity, Vitamin D Deficiency and Psychosis, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment
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.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 12 is below the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Ergocalciferols
2000 international units by mouth daily for 8 weeks.
Also known as: Drisdol
Change in Weight
Time frame: Baseline and 8 weeks
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
Time frame: Baseline and 8 weeks
Changes in Serum Levels of C-reactive Protein.
Time frame: Baseline and 8 weeks
HDL-cholesterol at Baseline and Post-treatment
Time frame: Baseline and 8 weeks
LDL-cholesterol at Baseline and Post-treatment
Time frame: Baseline and 8 weeks
Total Cholesterol at Baseline and Post-treatment
Time frame: Baseline and 8 weeks
Triglycerides at Baseline and Post-treatment
Time frame: Baseline and 8 weeks
Adiponectin at Baseline and Post-treatment
Time frame: Baseline and 8 weeks
Leptin at Baseline and Post-treatment
Time frame: Baseline and 8 weeks
| Milestone | Vitamin D |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
| kilograms | Vitamin D |
|---|---|
| Change in Weight | 0.07 ± 0.06 |
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
| HOMA-IR score | Vitamin D |
|---|---|
| Baseline | 3.01 ± 2.65 |
| Final (8 weeks) | 2.48 ± 2.00 |
No measurements were reported for this outcome.
| mg/dL | Vitamin D |
|---|---|
| Baseline | 43.4 ± 8.75 |
| Final (8 weeks) | 39.8 ± 9.35 |
| mg/dL | Vitamin D |
|---|---|
| Baseline | 102.00 ± 23.17 |
| Final (8 weeks) | 86.89 ± 29.60 |
| mg/dL | Vitamin D |
|---|---|
| Baseline | 173.67 ± 21.22 |
| Final (8 weeks) | 161.33 ± 20.35 |
| mg/dL | Vitamin D |
|---|---|
| Baseline | 189.7 ± 176.8 |
| Final (8 weeks) | 197.9 ± 121.31 |
| mcg/mL | Vitamin D |
|---|---|
| Baseline | 9.1 ± 4.75 |
| Final (8 weeks) | 8.9 ± 4.7 |
| ng/mL | Vitamin D |
|---|---|
| Baseline | 39.23 ± 22.54 |
| Final (8 weeks) | 43.69 ± 24.37 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D | — | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Vitamin D |
|---|---|
| <=18 years | 12 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Vitamin D |
|---|---|
| Mean | 16.6 ± 1.65 |
| Sex: Female, Male(Participants) | Vitamin D |
|---|---|
| Female | 4 |
| Male | 8 |
| Region of Enrollment(participants) | Vitamin D |
|---|---|
| United States | 12 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Worcester