NCT02135913

Brief Summary

This is a pilot study to determine the association between Vitamin D deficiency in obese children and low high density lipoprotein (HDL) and dysfunctional HDL.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2017

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

April 25, 2014

Last Update Submit

April 28, 2017

Conditions

ObeseVitamin D DeficiencyLow HDL

Keywords

ObeseChildrenVitamin D deficiencyLow HDL

Outcome Measures

Primary Outcomes (1)

  • Laboratory Analysis of Vitamin D blood levels before Vitamin D Supplementation

    Vitamin D deficiency in obese child leads to low HDL and dysfunctional HDL

    up to 24 months

Secondary Outcomes (1)

  • Laboratory Analysis of Vitamin D Blood Levels following Vitamin D Supplementation

    up to 24 months

Study Arms (1)

Viatamin D

EXPERIMENTAL

All children enrolled into the study will be prescribed standard of care vitamin D.

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

All subjects enrolled into the study will be prescribed standard of care Vitamin D

Viatamin D

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Obese children
  • Vitamin D deficiency
  • Low HDL

You may not qualify if:

  • HIV
  • Hepatitis A
  • Hepatitis B
  • Hepatitis C
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

ObesityVitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutrition

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Xiang An-Li, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2014

First Posted

May 12, 2014

Study Start

January 1, 2016

Primary Completion

April 26, 2017

Study Completion

April 26, 2017

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

US(1)