Vitamin D and Vascular Health in Children
Vitamin D and Vascular Function in Obese Children
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Primary Care Center, Children's Hospital of Pittsburgh of UPMC
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Vitamin D3 2000 IU
Vitamin D3 2000 IU tablet once daily by mouth for 6 months
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Tablet form
Outros nomes:
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Comparador Ativo: Vitamin D3 1000 IU
Vitamin D3 1000 IU tablet by mouth once daily for 6 months
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Tablet form
Outros nomes:
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Comparador de Placebo: Vitamin D3 600 IU
Vitamin D3 600 IU tablet by mouth once daily for 6 months
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Tablet form
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Flow-mediated Dilation (FMD) Percentage
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pulse-wave Velocity (PWV)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 6 months
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a measure of cardiometabolic health
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6 months
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Fasting Blood Glucose
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Body Mass Index (BMI)
Prazo: 6 months
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a surrogate measure of adiposity
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kumaravel Rajakumar, MD, MS, University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PRO12100034
- R01HL112985 (Concessão/Contrato do NIH dos EUA)
- 5R01HL112985-05 (Concessão/Contrato do NIH dos EUA)
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