Vitamin D and Vascular Health in Children
Vitamin D and Vascular Function in Obese Children
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- Primary Care Center, Children's Hospital of Pittsburgh of UPMC
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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 <20 ng/mL
Children taking multivitamins should be able to hold off their multivitamins during the course of the study.
Exclusion Criteria:
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Vitamin D3 2000 IU
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
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Tablet form
Altri nomi:
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Comparatore attivo: Vitamin D3 1000 IU
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
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Tablet form
Altri nomi:
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Comparatore placebo: Vitamin D3 600 IU
Vitamin D3 600 IU tablet by mouth once daily for 6 months
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Tablet form
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Flow-mediated Dilation (FMD) Percentage
Lasso di tempo: 6 months
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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.
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pulse-wave Velocity (PWV)
Lasso di tempo: 6 months
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PWV is a measure of arterial stiffness.
Higher values of PWV indicate greater degree of arterial stiffness.
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6 months
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Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)
Lasso di tempo: 6 months
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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. |
6 months
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Central Systolic Blood Pressure
Lasso di tempo: 6 months
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a measure of cardiometabolic health
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6 months
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Central Diastolic Blood Pressure
Lasso di tempo: 6 months
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a measure of cardiometabolic health
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6 months
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Systemic Systolic Blood Pressure
Lasso di tempo: 6 months
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a measure of cardiometabolic health
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6 months
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Systemic Diastolic Blood Pressure
Lasso di tempo: 6 months
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a measure of cardiometabolic health
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6 months
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Fasting Blood Glucose
Lasso di tempo: 6 months
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a measure of cardiometabolic health
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6 months
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1/Fasting Insulin Ratio
Lasso di tempo: 6 months
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1/fasting insulin ratio is a measure of insulin sensitivity.
Increases in 1/fasting insulin ratio indicate improvements in insulin sensitivity.
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6 months
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Body Mass Index (BMI)
Lasso di tempo: 6 months
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a surrogate measure of adiposity
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6 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Kumaravel Rajakumar, MD, MS, University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PRO12100034
- R01HL112985 (Sovvenzione/contratto NIH degli Stati Uniti)
- 5R01HL112985-05 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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