ObesityNCT01797302
Vitamin D and Vascular Health in Children
A study testing Vitamin D3 in people with Obesity and Vitamin D Deficiency, run by University of Pittsburgh at 1 site in United States.
Trial summary
In this study, we will test the central hypothesis that enhancement of vitamin D status in obese and overweight children will improve their vascular health and their cardiovascular disease (CVD) and metabolic syndrome risk profile. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 13 Aug 2018
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Eligible subjects will be 10 to 18 years of age;
- obese or overweight (BMI ≥85th %tile);
- otherwise healthy, and
- have a serum 25(OH)D concentration <20 ng/mL
- Children taking multivitamins should be able to hold off their multivitamins during the course of the study.
Who cannot join
- Children will be excluded if they
- (a) have hepatic or renal disease, metabolic rickets, malabsorptive disorders, primary hyperparathyroidism, hyperthyroidism, or other chronic disorders that could affect vitamin D metabolism;
- (b) are receiving treatment with anticonvulsants, systemic glucocorticoids, pharmacologic doses of vitamin D (≥1000 IU of vitamin D2 or D3 daily), antihypertensives, vasoactive drugs, antilipidemics, metformin, antipsychotics, or other oral insulin regulators;
- (c) have cholelithiasis or urolithiasis;
- (d) have type 1 or type 2 diabetes; or
- (e) have a condition or underlying abnormality that could compromise the safety of the subject.
- Post-menarchial girls with a positive pregnancy test at randomization, or subjects found during the screening phase to have hypercalcemia (serum calcium >10.8 mg/dL) or significant fasting hyperglycemia (fasting blood glucose ≥ 125 mg/dL) will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Care Center, Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Vitamin D and Vascular Function in Obese Children
In this study, we will test the central hypothesis that enhancement of vitamin D status in obese and overweight children will improve their vascular health and their cardiovascular disease (CVD) and metabolic syndrome risk profile.
Read the detailed description
Our primary objective is to determine, in obese and overweight children aged 10 to 18 years with vitamin D deficiency (defined as serum 25-hydroxyvitamin D <20 ng/mL), the efficacy of enhanced vitamin D3 supplementation in improving vascular endothelial function, arterial stiffness, insulin sensitivity, and metabolic syndrome risk status; and to assess whether these effects are dose-dependent. As a secondary objective, we will examine the vitamin D supplementation-induced effect on adipokines and inflammatory markers relevant to CVD risk. In a double-masked, controlled trial, we will randomize 252 eligible children to receive either 600 IU (conventional supplementation), or 1000 IU or 2000 IU (enhanced supplementation) of vitamin D3 daily for 6 months.
In terms of reporting of results, the following pre-specified outcomes are included in the primary manuscript (PubMed PMID:31950134 -- see Reference section for citation details)
- Waist Circumference
- Serum High Density Lipoprotein (HDL) Cholesterol
- Serum Triglycerides
- Inflammatory markers (Plasma TNF-alpha, high-sensitivity C-reactive protein, and IL-6)
- Adiopkines (Plasma Leptin and Adiponectin)
Plasma nitric oxide metabolites were not measured.
- Conditions
- Obesity, Vitamin D Deficiency
- Being tested
- Vitamin D3
- Keywords
- Obesity, Vitamin D Deficiency, Vascular Function, Insulin resistance, metabolic syndrome
- Medical subject headings
- Obesity, Vitamin D Deficiency, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Tablet form
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 2000 IU | Active comparator | Vitamin D3 2000 IU tablet once daily by mouth for 6 months Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D3 1000 IU | Active comparator | Vitamin D3 1000 IU tablet by mouth once daily for 6 months Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D3 600 IU | Placebo comparator | Vitamin D3 600 IU tablet by mouth once daily for 6 months Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated Dilation (FMD) Percentage
Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100.
Measured: 6 months
Secondary outcomes (8)
Pulse-wave Velocity (PWV)
PWV is a measure of arterial stiffness. Higher values of PWV indicate greater degree of arterial stiffness.
Measured: 6 months
Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)
AIx-75 is a measure of arterial stiffness. AIx was measured through radial arterial tonometry using SphygmoCor.
Radial pulse waveform are analyzed through an automatic software function to determine aortic pulse waveform and aortic or central systolic (cSBP) and diastolic blood pressure (cDBP), and these measurements are further analyzed automatically to calculate AIx.
AIx is a composite measure of the magnitude of wave reflection and arterial stiffness in all conduit arteries which affect the timing of the wave reflection. AIx = P2-P1/cSBP-cDBP, where P1 is the height of the incident pressure wave form during systole, P2 is the height of the reflected wave added to the incident wave, cSBP is the aortic systolic BP, and cDBP is the aortic diastolic BP. AIx adjusted to heart rate of 75 beats/min (AIx-75) is a validated index of arterial stiffness, with higher values indicating higher degree of arterial stiffness.
Measured: 6 months
Central Systolic Blood Pressure
a measure of cardiometabolic health
Measured: 6 months
Central Diastolic Blood Pressure
a measure of cardiometabolic health
Measured: 6 months
Systemic Systolic Blood Pressure
a measure of cardiometabolic health
Measured: 6 months
Systemic Diastolic Blood Pressure
a measure of cardiometabolic health
Measured: 6 months
Fasting Blood Glucose
a measure of cardiometabolic health
Measured: 6 months
1/Fasting Insulin Ratio
1/fasting insulin ratio is a measure of insulin sensitivity. Increases in 1/fasting insulin ratio indicate improvements in insulin sensitivity.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startAug 2013
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
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 University of PittsburghThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)
- Responsible party
- Principal investigator, Kumaravel Rajakumar, University of Pittsburgh
- Investigators
- Kumaravel Rajakumar, MD, MS, Principal investigator, University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797302
- Sponsor's protocol ID
- PRO12100034
- Other IDs
- R01HL112985, 5R01HL112985-05
- Status last verified
- Jun 2020
- First submitted
- 20 Feb 2013
- Last updated
- 24 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rajakumar K, Moore CG, Khalid AT, Vallejo AN, Virji MA, Holick MF, Greenspan SL, Arslanian S, Reis SE. Effect of vitamin D3 supplementation on vascular and metabolic health of vitamin D-deficient overweight and obese children: a randomized clinical trial. Am J Clin Nutr. 2020 Apr 1;111(4):757-768. doi: 10.1093/ajcn/nqz340.
PubMed 31950134
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Vascular Function in Obese Children
- ClinicalTrials.gov ID
- NCT01797302
- Acronym / sponsor ID
- PRO12100034
- Conditions
- Obesity, Vitamin D Deficiency
- Keywords
- Obesity, Vitamin D Deficiency, Vascular Function, Insulin resistance, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)
- Study start
- Aug 2013 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 24 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we will test the central hypothesis that enhancement of vitamin D status in obese and overweight children will improve their vascular health and their cardiovascular disease (CVD) and metabolic syndrome risk profile.
Detailed description
Our primary objective is to determine, in obese and overweight children aged 10 to 18 years with vitamin D deficiency (defined as serum 25-hydroxyvitamin D <20 ng/mL), the efficacy of enhanced vitamin D3 supplementation in improving vascular endothelial function, arterial stiffness, insulin sensitivity, and metabolic syndrome risk status; and to assess whether these effects are dose-dependent. As a secondary objective, we will examine the vitamin D supplementation-induced effect on adipokines and inflammatory markers relevant to CVD risk. In a double-masked, controlled trial, we will randomize 252 eligible children to receive either 600 IU (conventional supplementation), or 1000 IU or 2000 IU (enhanced supplementation) of vitamin D3 daily for 6 months.
In terms of reporting of results, the following pre-specified outcomes are included in the primary manuscript (PubMed PMID:31950134 -- see Reference section for citation details)
- Waist Circumference
- Serum High Density Lipoprotein (HDL) Cholesterol
- Serum Triglycerides
- Inflammatory markers (Plasma TNF-alpha, high-sensitivity C-reactive protein, and IL-6)
- Adiopkines (Plasma Leptin and Adiponectin)
Plasma nitric oxide metabolites were not measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 2000 IU | Active comparator | Dietary Supplement: Vitamin D3Vitamin D3 2000 IU tablet once daily by mouth for 6 months |
| Vitamin D3 1000 IU | Active comparator | Dietary Supplement: Vitamin D3Vitamin D3 1000 IU tablet by mouth once daily for 6 months |
| Vitamin D3 600 IU | Placebo comparator | Dietary Supplement: Vitamin D3Vitamin D3 600 IU tablet by mouth once daily for 6 months |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Eligible subjects will be 10 to 18 years of age;
- obese or overweight (BMI ≥85th %tile);
- otherwise healthy, and
- have a serum 25(OH)D concentration <20 ng/mL
- Children taking multivitamins should be able to hold off their multivitamins during the course of the study.
Key exclusion criteria (7 listed)
- Children will be excluded if they
- (a) have hepatic or renal disease, metabolic rickets, malabsorptive disorders, primary hyperparathyroidism, hyperthyroidism, or other chronic disorders that could affect vitamin D metabolism;
- (b) are receiving treatment with anticonvulsants, systemic glucocorticoids, pharmacologic doses of vitamin D (≥1000 IU of vitamin D2 or D3 daily), antihypertensives, vasoactive drugs, antilipidemics, metformin, antipsychotics, or other oral insulin regulators;
- (c) have cholelithiasis or urolithiasis;
- (d) have type 1 or type 2 diabetes; or
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 D3Also: CholecalciferolTablet form | Dietary supplement | Vitamin D3 1000 IU, Vitamin D3 2000 IU, Vitamin D3 600 IU |
Primary outcome
Flow-mediated Dilation (FMD) Percentage
Time frame: 6 months
Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100.
8 secondary outcomes
Pulse-wave Velocity (PWV)
Time frame: 6 months
Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)
Time frame: 6 months
Central Systolic Blood Pressure
Time frame: 6 months
Central Diastolic Blood Pressure
Time frame: 6 months
Systemic Systolic Blood Pressure
Time frame: 6 months
Systemic Diastolic Blood Pressure
Time frame: 6 months
Fasting Blood Glucose
Time frame: 6 months
1/Fasting Insulin Ratio
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31950134Rajakumar K, Moore CG, Khalid AT, Vallejo AN, Virji MA, Holick MF, Greenspan SL, Arslanian S, Reis SE. Effect of vitamin D3 supplementation on vascular and metabolic health of vitamin D-deficient overweight and obese children: a randomized clinical trial. Am J Clin Nutr. 2020 Apr 1;111(4):757-768. doi: 10.1093/ajcn/nqz340.
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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.
Kumaravel Rajakumar, MD, MS principal investigator
University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
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 D3 in people with Obesity and Vitamin D Deficiency, run by University of Pittsburgh 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 5 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 24 Jun 2020. 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 24 Jun 2020). 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?
Flow-mediated Dilation (FMD) Percentage (time frame: 6 months). 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 NCT01797302, 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 24 Jun 2020.