ObesityNCT01217840
Effect of Vitamin D Supplementation on Inflammation and Cardiometabolic Risk Factors in Obese Adolescents
A study testing Drisdol (Ergocalciferol) Vitamin D2 in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- Drisdol (Ergocalciferol) Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 11 years to 17.99 years old
- BMI: 85 percentile for age and gender
Who cannot join
- Patients who currently receive:
- vitamin D supplementation >= 400 IU/day
- daily glucocorticoids or anti-epileptics
- Patients who currently have or history of:
- 25-OH vitamin D level < 10 ng/ml or > 60 ng/ml
- rickets
Show all 12Show fewer
- diabetes mellitus
- liver or kidney disease
- malabsorptive disorders
- genetic syndromes associated with obesity (i.e. Prader-Willi)
- lactose deficiency or insufficiency
- galactosemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents
Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher.
Vitamin D is essential for the body to maintain normal calcium levels and strong bones. Recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin D plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat.
Read more
The purpose of this study is to determine the effect of vitamin D supplementation on inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin D stores and inflammatory cytokines.
In an observed, randomized controlled trial over 6 months we will provide observed vitamin D supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that administration of vitamin D to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).
Read the detailed description
Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum 25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese youth. Further studies are needed to establish the dose of vitamin D required to increase 25OHD and determine potential effects on metabolic risk factors in obese teens.
During the course of the study, blood pressure removed from the prespecified outcome measures.
- Conditions
- Obesity
- Being tested
- Drisdol (Ergocalciferol) Vitamin D2, Placebo
- Keywords
- Adolescents, Vitamin D
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drisdol (Ergocalciferol) Vitamin D2Drug
Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
PlaceboDrug
Placebo pill - 3 pills every 12 weeks for total of 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Experimental | Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.
Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Receives: Drug: Drisdol (Ergocalciferol) Vitamin D2 |
| Placebo | Placebo comparator | Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
25OH Vitamin D
Primary outcome is serum 25OH vitamin D concentrations
Measured: Baseline; Week 24
Secondary outcomes (8)
Triglycerides at Baseline and Week 24
Measured: Baseline; Week 24
High-density Lipoprotein (HDL) at Baseline and Week 24
Measured: Baseline; Week 24
Hemoglobin A1C (HgbA1c) at Baseline and Week 24
HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months.
Measured: Baseline; Week 24
Interleukin-6 (IL-6) at Baseline and Week 24
Measured: Baseline; Week 24
Interleukin-10 (IL-10) at Baseline and Week 24
Measured: Baseline; Week 24
Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24
Measured: Baseline; Week 24
C-reactive Protein (CRP) at Baseline and Week 24
Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test.
Measured: Baseline; Week 24
Adiponectin at Baseline and Week 24
Measured: Baseline; Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura K Bachrach, Stanford University
- Investigators
- Laura K Bachrach, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217840
- Sponsor's protocol ID
- SU-10012010-6989
- Other IDs
- 18885
- Status last verified
- Oct 2017
- First submitted
- 7 Oct 2010
- Last updated
- 29 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shah S, Wilson DM, Bachrach LK. Large Doses of Vitamin D Fail to Increase 25-Hydroxyvitamin D Levels or to Alter Cardiovascular Risk Factors in Obese Adolescents: A Pilot Study. J Adolesc Health. 2015 Jul;57(1):19-23. doi: 10.1016/j.jadohealth.2015.02.006. Epub 2015 Apr 11.
PubMed 25873553
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D on Cytokines and Cardiometabolic Risk in Obese Adolescents
- ClinicalTrials.gov ID
- NCT01217840
- Acronym / sponsor ID
- SU-10012010-6989
- Conditions
- Obesity
- Keywords
- Adolescents, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher.
Vitamin D is essential for the body to maintain normal calcium levels and strong bones. Recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin D plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat.
The purpose of this study is to determine the effect of vitamin D supplementation on inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin D stores and inflammatory cytokines.
In an observed, randomized controlled trial over 6 months we will provide observed vitamin D supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that administration of vitamin D to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).
Detailed description
Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum 25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese youth. Further studies are needed to establish the dose of vitamin D required to increase 25OHD and determine potential effects on metabolic risk factors in obese teens.
During the course of the study, blood pressure removed from the prespecified outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Experimental | Drug: Drisdol (Ergocalciferol) Vitamin D2Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboSubjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Ages 11 years to 17.99 years old
- BMI: 85 percentile for age and gender
Key exclusion criteria (12 listed)
- Patients who currently receive:
- Patients who currently have or history of:
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 |
|---|---|---|
| Drisdol (Ergocalciferol) Vitamin D2Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks. | Drug | vitamin D |
| PlaceboPlacebo pill - 3 pills every 12 weeks for total of 24 weeks | Drug | Placebo |
Primary outcome
25OH Vitamin D
Time frame: Baseline; Week 24
Primary outcome is serum 25OH vitamin D concentrations
8 secondary outcomes
Triglycerides at Baseline and Week 24
Time frame: Baseline; Week 24
High-density Lipoprotein (HDL) at Baseline and Week 24
Time frame: Baseline; Week 24
Hemoglobin A1C (HgbA1c) at Baseline and Week 24
Time frame: Baseline; Week 24
Interleukin-6 (IL-6) at Baseline and Week 24
Time frame: Baseline; Week 24
Interleukin-10 (IL-10) at Baseline and Week 24
Time frame: Baseline; Week 24
Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24
Time frame: Baseline; Week 24
C-reactive Protein (CRP) at Baseline and Week 24
Time frame: Baseline; Week 24
Adiponectin at Baseline and Week 24
Time frame: Baseline; Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25873553Shah S, Wilson DM, Bachrach LK. Large Doses of Vitamin D Fail to Increase 25-Hydroxyvitamin D Levels or to Alter Cardiovascular Risk Factors in Obese Adolescents: A Pilot Study. J Adolesc Health. 2015 Jul;57(1):19-23. doi: 10.1016/j.jadohealth.2015.02.006. Epub 2015 Apr 11.
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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.
Laura K Bachrach principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drisdol (Ergocalciferol) Vitamin D2 in people with Obesity, run by Stanford University 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 2 inclusion and 12 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 29 Nov 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?
Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
25OH Vitamin D (time frame: Baseline; Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217840, which also lists 1 linked publication.
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 29 Nov 2017.