N/A
N=225
Vitamin D and Vascular Health in Children
Obesity · Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01797302 ↗Enrolled (actual)
225
Serious AEs
0.4%
Results posted
Jun 2020
Primary outcome: Primary: Flow-mediated Dilation (FMD) Percentage — 7.61; 8.27; 7.31 percentage of baseline dilation — p=0.88
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D3 (Dietary_supplement)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow-mediated Dilation (FMD) Percentage |
7.61; 8.27; 7.31 | 0.88 |
| SECONDARY Pulse-wave Velocity (PWV) |
4.85; 4.85; 4.88 | 0.85 |
| SECONDARY Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75) |
3.75; 2.22; 1.74 | 0.61 |
| SECONDARY Central Systolic Blood Pressure |
98.45; 96.05; 98.50 | 0.24 |
| SECONDARY Central Diastolic Blood Pressure |
68.69; 65.33; 68.57 | 0.0117 sig |
| SECONDARY Systemic Systolic Blood Pressure |
114.71; 114.88; 115.70 | 0.53 |
| SECONDARY Systemic Diastolic Blood Pressure |
67.57; 64.73; 67.30 | 0.0256 sig |
| SECONDARY Fasting Blood Glucose |
88.41; 88.48; 90.44 | 0.0945 |
| SECONDARY 1/Fasting Insulin Ratio |
0.08; 0.06; 0.06 | 0.12 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 10.8 mg/dL) or significant fasting hyperglycemia (fasting blood glucose ≥ 125 mg/dL) will also be excluded.
Data sourced from ClinicalTrials.gov (NCT01797302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.