Vitamin D DeficiencyNCT02414529
Efficacy of Vitamin D Therapy on Glucose Homeostasis in Obese Adolescents
A study testing Vitamin D2 in people with Vitamin D Deficiency, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
- 12- 18 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)
- 25-OH vitamin D level less than 20 ng/ml (50 nmol/liter)
- Subjects must be willing to comply with study protocol requirements
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D2, Placebo
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Drug
Also called ergocalciferol, Vitamin D
Ergocalciferol 5000 units capsules given. 300,000 units PO once.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Vitamin D2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Body Insulin Sensitivity (WBISI)
measured by the OGTT
Measured: 18 weeks
Insulinogenic index
meassured by OGT
Measured: 18 weeks
Secondary outcomes (3)
Vitamin D 25 OH
pre and post treatment changes in serum vitamin D 25 OH.
Measured: 18 weeks
PTH level
changes in the level PTH pre and post treatment
Measured: 18 weeks
Vitamin D toxicity
will measure metabolic profile to monitor toxicity such us: calcium level in serum and urine, phosphate, vitamin D
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Preneet Brar, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414529
- Sponsor's protocol ID
- 12-03213
- Status last verified
- Mar 2017
- First submitted
- 1 Apr 2015
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin D Therapy on Glucose Homeostasis in Obese Adolescents
- ClinicalTrials.gov ID
- NCT02414529
- Acronym / sponsor ID
- 12-03213
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo group B: single blinded to patients, receive 6 capsule PO (placebo) at once. Subjects are blinded then they will crossover groups |
| Treatment group | Active comparator | Drug: Vitamin D2Group A will receive 6 capsules (50.000 units/each) of vitamin D2(ergocalciferol) at once. Subjects are blinded then they will crossover groups. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
- 12- 18 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)
- 25-OH vitamin D level less than 20 ng/ml (50 nmol/liter)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2Also: ergocalciferol, Vitamin DErgocalciferol 5000 units capsules given. 300,000 units PO once. | Drug | Treatment group |
| Placebo | Drug | Placebo group |
Primary outcome
Whole Body Insulin Sensitivity (WBISI)
Time frame: 18 weeks
measured by the OGTT
Insulinogenic index
Time frame: 18 weeks
meassured by OGT
3 secondary outcomes
Vitamin D 25 OH
Time frame: 18 weeks
PTH level
Time frame: 18 weeks
Vitamin D toxicity
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preneet Brar principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D2 in people with Vitamin D Deficiency, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Body Insulin Sensitivity (WBISI) (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.