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Vitamin Supplement

Vitamin D for Obesity

Phase 4
Waitlist Available
Led By Maria Vogiatzi, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

The discovery that the vitamin D receptor is expressed in more than 30 tissues indicates that the physiologic functions of vitamin D are much broader than its well-known role in the regulation of calcium absorption and bone metabolism. There is evidence that vitamin D is involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type I diabetes. Recent epidemiological evidence points to a strong association between vitamin D insufficiency and insulin resistance, the metabolic syndrome, and type II diabetes. The investigators would like to examine the role of vitamin D in the development of insulin resistance in overweight children and adolescents, which represent a high risk population for cardiovascular and metabolic complications. The investigators propose a prospective randomized clinical trial of vitamin D supplementation in overweight, insulin resistant, vitamin D deficient children. The investigators objective is to assess if changes in insulin resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these patients post treatment with vitamin D. Additionally, concomitant changes in calcium and bone metabolism after vitamin D treatment will be evaluated. This is because, contrary to adults, the optimal vitamin D concentrations that regulate calcium and bone metabolism have not been established in pediatrics.

Eligible Conditions
  • Obesity
  • Vitamin D Deficiency
  • Insulin Resistance

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine changes in insulin sensitivity induced by vitamin D supplementation in obese children with insulin resistance.
Secondary outcome measures
To quantify the associations between vitamin D 25 concentration, insulin resistance, and calcium metabolism in overweight children.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vitamin DActive Control1 Intervention
Subjects will randomly be assigned to Vitamin D drops versus placebo drops.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will randomly be assigned to Vitamin D drops versus placebo drops.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,199 Total Patients Enrolled
16 Trials studying Obesity
14,124 Patients Enrolled for Obesity
Maria Vogiatzi, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

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~8 spots leftby Apr 2025