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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.
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.
Primary Outcome
Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia. From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostas
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Vitamin D3
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT00858247 record still lists
NCT00858247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00858247's enrollment target sits among peer trials
51 709th of 1053 higher than 341 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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