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NCT00858247 · ClinicalTrials.gov registry record · Phase 2

Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in Obese Adolescents

A Phase 2 study of Obesity, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
51
Enrollment target
1
Study location

NCT00858247: Completed Phase 2 study of Obesity, sponsored by Mayo Clinic.

NCT00858247 is a Phase 2 study of Obesity that has completed, run by Mayo Clinic. The registered enrollment target is 51 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00858247, a Phase 2 study of Obesity, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
51 participants
Enrollment target
1
Study location

Study Summary

The prevalence of obesity has reached epidemic proportions nationally as well as internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to vitamin D insufficient. In adults, low vitamin D status appears to be associated with the development of type 2 diabetes and metabolic syndrome. There is little information on the prevalence of vitamin D insufficiency and its implications in obese adolescents. Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents might result in improvement in insulin resistance, lipids and cardiovascular risk markers. We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves insulin resistance and cardiovascular risk factors in this population. The purpose of the study is to determine the impact of vitamin D3 supplementation on various parameters of insulin secretion, insulin action, lipids and C-reactive protein in obese adolescents.

Conditions Studied

Obesity

Interventions

  • DIETARY_SUPPLEMENT Vitamin D3

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2009-04
Est. Completion 2012-12
Phase Phase 2

Sponsor

Mayo Clinic

2,844 total trials

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What the Registry Record Tells You About NCT00858247

The ClinicalTrials.gov registry entry for NCT00858247 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Vitamin D3 is the first listed.

NCT00858247 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT00858247 about?

NCT00858247 is a clinical study titled "Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in Obese Adolescents". The prevalence of obesity has reached epidemic proportions nationally as well as internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to vitamin D insufficient. In adults, low...

What is the current status of trial NCT00858247?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2009-04. Estimated completion is 2012-12.

What conditions does trial NCT00858247 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT00858247?

The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00858247?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00858247 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.