Efficacy of Vitamin D Therapy on Glucose Homeostasis in Obese Adolescents

March 15, 2017 updated by: NYU Langone Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participation will involve 3 visits (6 weeks apart) to the Clinical and Translational Science Institute (CTSI), which should happen 2-3 weeks after you have consented to participate in this study. The total duration of the study and the time you/your child will spend in the CTSI will be 2.5 hours for each visit.

Number of adolescents/children will enroll in this study:20.

Visit 1 A doctor will perform a complete physical examination. The child will have his/her weight and height measured .Blood pressure and vital signs will check each visit.

Of the 2 hours spent in the hospital, 1/2 hour is allocated to getting measurements, weight, and vitals and putting in an intravenous line and drawing fasting labs. The oral glucose tolerance test will take about 2 hours. To test for insulin sensitivity (Risk marker of Diabetes), oral Glucose Tolerance Test (OGTT) will be done. OGTT is used to diagnose Diabetes and Pre Diabetes. The child will first have blood samples drawn, and then will drink oral glucose soda. Blood samples will be obtained over 2 hours. A total of 5-7 teaspoons, which is 25-35 cc of blood will be taken during this test. Of this 15 cc will be drawn during the OGTT. A doctor or nurse will be monitoring the child throughout the test. If he/she develops low blood sugar, they will be treated appropriately with glucose.

Blood samples obtained at the start of the OGTT will be used to measure various markers of insulin sensitivity, vitamin D level and marker of bone health as vitamin D deficiency can causebone loss. This blood will be stored in the CTSI core laboratory in the CTSI for duration of this study. The blood samples will be stored without child's name or any other identifying information on them. The samples will be destroyed once the study is completed.

After the OGTT done, your child will receive a one time high dose of vitamin D (group A) or placebo (capsule containing no medication) (Group B). This way of treating of low vitamin D levels with one time high dose of vitamin D is safe and has been studied in adolescents.

The child has 50/50 chance to be in either group. Neither he/she nor you will know if he/she is getting Vit D or placebo. At week 7, your child needs to return to CTSI for 2nd study for physical check-up, blood test and urine test using the same method as the 1st visit. The urine testing will be done to test for urinary calcium as this could be a sign of vitamin D toxicity.

After the 2nd study done, your child will be reassigned to alternate treatment group and will receive either vitamin D or placebo. That means that if he/she was getting a placebo at the first visit then he/she will get a real Vit D this time. If he/she was getting vit D at the first visit, he/she will get a placebo at this visit.

At week 12 after completion of the 2nd course of medication, you and your child will have to come back for the final blood and urine study using the same method as the first and 2nd study.

At this your child will have an oral glucose tolerance test, blood and urine tests. The urine testing will be done to test for urinary calcium as this could be a sign of vitamin D toxicity. If your child has high urine calcium he/she will not be allowed to participate in the study We guarantee that your child will receive the treatment for lack of vitamin D either the first half or latter half of the study. However, you will not know what medication your child will receive during the entire study. We will set an appointment to see us in 2weeks at the Endocrine clinic; however, it will be not part of the study. We will go over the results of the study at that time and will see if any further treatment with Vitamin D is required for your adolescent.

You and your child will have to come back to CTSI at the end of week 12 for post-therapy study. After a minimum 10-hour fast, participants will come to the CTSI, during which your child will have his/her weight and height measured. Blood Pressure will be measured. Post vitamin D therapy OGTT. Vitamin D level and markers for bone health will again be measured using same method as day 1. Urine will be collected for urinary calcium level, using same method as day 1.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • bellevue hospital CTSI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Pubertal: Testicular volume ≥ 6 ml Prader (M) and Tanner III breast development or greater (F)
  3. 12- 18 years regardless of gender, race or economic circumstance
  4. Pre diabetes/high risk of diabetes using criteria of HbA1C between 5.7 - 6.4% as defined by the American Diabetes Association (ADA)
  5. 25-OH vitamin D level less than 20 ng/ml (50 nmol/liter)
  6. Subjects must be willing to comply with study protocol requirements

Exclusion Criteria:

  1. 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).
  2. 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.
  3. Significant major organ system illness
  4. History of nephrolithiasis or hypercalcemia
  5. Females who are pregnant
  6. Significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse, and uncontrolled major depression.
  7. Attendance at tanning salon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group

Placebo group B: single blinded to patients, receive 6 capsule PO (placebo) at once.

Subjects are blinded then they will crossover groups
Drug: Placebo
Active Comparator: Treatment group

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
Ergocalciferol 5000 units capsules given. 300,000 units PO once.
Other Names:
  • ergocalciferol, Vitamin D

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Whole Body Insulin Sensitivity (WBISI)
Time Frame: 18 weeks
measured by the OGTT
18 weeks
Insulinogenic index
Time Frame: 18 weeks
meassured by OGT
18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vitamin D 25 OH
Time Frame: 18 weeks
pre and post treatment changes in serum vitamin D 25 OH.
18 weeks
PTH level
Time Frame: 18 weeks
changes in the level PTH pre and post treatment
18 weeks
Vitamin D toxicity
Time Frame: 18 weeks
will measure metabolic profile to monitor toxicity such us: calcium level in serum and urine, phosphate, vitamin D
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Preneet Brar, NYU School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12-03213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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