N/A
Completed N=12
Vitamin D Supplementation in Psychiatric Illnesses
Source: ClinicalTrials.gov NCT01004354 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcomePrimary: Change in Weight — 0.07 kilograms
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
0.07 | — |
| SECONDARY Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment |
3.01; 2.48 | — |
| SECONDARY Changes in Serum Levels of C-reactive Protein. |
— | — |
| SECONDARY HDL-cholesterol at Baseline and Post-treatment |
43.4; 39.8 | — |
| SECONDARY LDL-cholesterol at Baseline and Post-treatment |
102.00; 86.89 | — |
| SECONDARY Total Cholesterol at Baseline and Post-treatment |
173.67; 161.33 | — |
| SECONDARY Triglycerides at Baseline and Post-treatment |
189.7; 197.9 | — |
| SECONDARY Adiponectin at Baseline and Post-treatment |
9.1; 8.9 | — |
| SECONDARY Leptin at Baseline and Post-treatment |
39.23; 43.69 | — |
Eligibility Criteria
Inclusion Criteria
- Males/females between the ages 10 through 18 years,
- Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)[62] Axis 1 diagnosis who are on treatment with SGA. These conditions include schizophrenia, schizo-affective disorder, and psychosis,
- Subjects who have gained 10% of their pre-drug body weight while receiving the following SGAs: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. Subjects could be taking other psychotropic agents, but only one SGA,
- All subjects will be able to take the prescribed vitamin D by mouth,
- All subjects will have a 25-hydroxyvitamin D level of < 32 ng/mL,
- All subjects must reside in an in-patient psychiatric facility.
Exclusion Criteria
- Pregnant or lactating women,
- Patients with mental retardation (intelligence quotient < 50),
- Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases,
- Subjects with known history of parathyroid disorder,
- Subjects with acquired or congenital disorders of vitamin D metabolism,
- Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol,
- Subjects taking any weight loss medications, such as orlistat, and sibutramine,
- Subjects on medications that might affect glucose levels, such as insulin or metformin.
Data sourced from ClinicalTrials.gov (NCT01004354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.