Phase 1 N=19 Prevention

Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents

Obesity · Endothelial Dysfunction · Vitamin D Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT01746264 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Flow Mediated Dilatation (FMD) — 9.5; 10.4 percentage increase in BAD — p=0.59

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Vitamin D3 (Dietary_supplement)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Flow Mediated Dilatation (FMD)	9.5; 10.4	0.59
SECONDARY 25-hydroxy Vitamin D (25[OH]D) Levels	55.9; 86.9	<0.001 sig
SECONDARY Total Cholesterol	3.69; 4.03	<0.01 sig
SECONDARY Triglycerides	1.19; 1.58	—
SECONDARY Body Mass Index	36.1; 36.4	0.32
SECONDARY International Physical Activity Questionnaire (IPAQ) Short Form Score	1786.6; 2799.1	0.21
SECONDARY Calcium Intake Per Day	1102.7; 975.5	0.02 sig
SECONDARY Serum Parathyroid Hormone (PTH)	4.1; 3.3	0.0123 sig
SECONDARY Fasting Glucose	4.9; 4.97	0.09
SECONDARY Fasting Insulin	225.71; 245.16	0.27
SECONDARY Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)	7.11; 7.9	0.18
SECONDARY High Sensitivity C-reactive Protein (Hs-CRP)	47.62; 40	0.33
SECONDARY Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels	1.95; 2.15	0.05
SECONDARY High Density Lipoprotein (HDL) Cholesterol Levels	1.2; 1.16	0.41
SECONDARY Urine Calcium to Creatinine Ratio	67.8; 87.7	0.32
SECONDARY Reactive Hyperemia Index (RHI)	449.3; 513.9	0.47

Summary

Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents have a high prevalence of Vitamin D deficiency as well as evidence of endothelial dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with Vitamin D would lead to improvement in endothelial dysfunction.

Eligibility Criteria

Inclusion Criteria

Age 12-18 years
BMI >95% for age and gender
25 (OH) D levels less than 30 ng/ml

Exclusion Criteria

25 (OH) D levels >30 ng/mL
Serum calcium >10.4 mg/dL
Serum phosphorus > 4.7 mg/dl
Pregnancy or nursing
Current cancer
Patients on vitamin D3 supplementation exceeding 400 IU/day
Hypertension defined as Blood Pressure over the 95th percentile for age, gender and height
Dietary calcium intake exceeding 1500 mg/day
Hepatic or renal disorders
Type 1 or type 2 diabetes mellitus
Subjects receiving insulin, metformin, or oral hypoglycemic medications
Subjects with malabsorption disorders (celiac disease, cystic fibrosis, inflammatory bowel disease)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01746264). 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.