NCT02414529

Brief Summary

The purpose of this study is to see whether giving a Vitamin D supplement to vitamin D deficient obese children and adolescents will decrease the risk of getting diabetes (Disease in which the person has high blood sugar). The number of vitamin D deficiency in U.S. children and teenagers has grown dramatically over the past 30 years. There are some reports suggesting that vitamin D supplementation in adults with pre diabetes (blood glucose higher than normal) and vitamin D treatment will prevent diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

April 1, 2015

Last Update Submit

March 15, 2017

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

  • Whole Body Insulin Sensitivity (WBISI)

    measured by the OGTT

    18 weeks

  • Insulinogenic index

    meassured by OGT

    18 weeks

Secondary Outcomes (3)

  • Vitamin D 25 OH

    18 weeks

  • PTH level

    18 weeks

  • Vitamin D toxicity

    18 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Placebo group B: single blinded to patients, receive 6 capsule PO (placebo) at once. Subjects are blinded then they will crossover groups

Drug: Placebo

Treatment group

ACTIVE COMPARATOR

Group A will receive 6 capsules (50.000 units/each) of vitamin D2(ergocalciferol) at once. Subjects are blinded then they will crossover groups.

Drug: Vitamin D2

Interventions

Vitamin D2DRUG

Ergocalciferol 5000 units capsules given. 300,000 units PO once.

Also known as: ergocalciferol, Vitamin D
Treatment group
PlaceboDRUG
Placebo group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Obese subjects - BMI at or above the 95th percentile for children of the same age and sex. Only obese subjects will be selected given that they are the highest risk group of developing insulin resistance and Type II Diabetes and therefore with be most likely to demonstrate glucose pertubation.
  • Pubertal: Testicular volume ≥ 6 ml Prader (M) and Tanner III breast development or greater (F)
  • years regardless of gender, race or economic circumstance
  • Pre diabetes/high risk of diabetes using criteria of HbA1C between 5.7 - 6.4% as defined by the American Diabetes Association (ADA)
  • OH vitamin D level less than 20 ng/ml (50 nmol/liter)
  • Subjects must be willing to comply with study protocol requirements

You may not qualify if:

  • Treatment on medication known to effect vitamin D, calcium and glucose metabolism, such as glucocorticoids, thiazolidinediones, metformin, anticonvulsants metabolized through cytochrome P-450 (phenytoin, carbamazepine, phenobarbital, sodium valproate).
  • Subjects will be excluded from the study if they have taken any form of vitamin D supplementation greater than 400 IU daily in the preceding 3 months.
  • Significant major organ system illness
  • History of nephrolithiasis or hypercalcemia
  • Females who are pregnant
  • Significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse, and uncontrolled major depression.
  • Attendance at tanning salon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

bellevue hospital CTSI

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

ErgocalciferolsVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Preneet Brar

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 10, 2015

Study Start

November 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

US(1)