ObesityVDSSNCT01004354
Vitamin D Supplementation in Psychiatric Illnesses
A study testing Ergocalciferols in people with Obesity and Vitamin D Deficiency, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity, Vitamin D Deficiency, Psychosis
- What is being tested?
- Ergocalciferols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
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.
Read the detailed description
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
- Being tested
- Ergocalciferols
- Keywords
- Psychiatric illnesses, Vitamin D deficiency, Obesity
- Medical subject headings
- Obesity, Vitamin D Deficiency, Psychotic Disorders, Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolsDrug
Also called Drisdol
2000 international units by mouth daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Not described Receives: Drug: Ergocalciferols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured: Baseline and 8 weeks
Secondary outcomes (8)
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
Measured: Baseline and 8 weeks
Changes in Serum Levels of C-reactive Protein.
Measured: Baseline and 8 weeks
HDL-cholesterol at Baseline and Post-treatment
Measured: Baseline and 8 weeks
LDL-cholesterol at Baseline and Post-treatment
Measured: Baseline and 8 weeks
Total Cholesterol at Baseline and Post-treatment
Measured: Baseline and 8 weeks
Triglycerides at Baseline and Post-treatment
Measured: Baseline and 8 weeks
Adiponectin at Baseline and Post-treatment
Measured: Baseline and 8 weeks
Leptin at Baseline and Post-treatment
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin U. Nwosu, University of Massachusetts, Worcester
- Investigators
- Benjamin U Nwosu, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004354
- Sponsor's protocol ID
- Docket #13212
- Acronym
- VDSS
- Status last verified
- Nov 2017
- First submitted
- 28 Oct 2009
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01004354
- Acronym / sponsor ID
- VDSS / Docket #13212
- Keywords
- Psychiatric illnesses, Vitamin D deficiency, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Posted 10 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Ergocalciferols |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgocalciferolsAlso: Drisdol2000 international units by mouth daily for 8 weeks. | Drug | Vitamin D |
Primary outcome
Change in Weight
Time frame: Baseline and 8 weeks
8 secondary outcomes
Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin U Nwosu, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergocalciferols in people with Obesity and Vitamin D Deficiency, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.