25-Hydroxyvitamin D Levels Are Negatively Associated With Platelets Number in a Cohort of Overweight and Obese Subjects

Completed

• Conditions: Obesity

• Registration Number: NCT04133441
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief Summary

This study was aimed to investigate the associations between platelet number and 25(OH)D serum concentration in apparently healthy but overweight/obese subjects.

Detailed Description

Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. We provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP) and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters. To lead the statistical analysis, all sample was clusterized into three different groups according to the diagnostic condition of deficiency (\<10 ng/mL), insufficiency (\<20 ng/mL) and sufficiency (≥20 ng/mL) of vitamin D. We labelled each cluster as group 1, group 2 and group 3.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Last Update Submitted: 2019-10-18
• Study First Posted: 2019-10-21
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

• Overweight or obesity (BMI> 25 Kg/m2)

Exclusion Criteria

• Any kind of drug
• Hypertension
• Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
• Chronic inflammatory diseases
• Renal failure
• Liver failure
• Angina pectoris
• Myocardial infarction and heart failure
• Genetic heart diseases
• Thrombocytopenias

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitamin D	At baseline	Vitamin D (ng/mL) concentration in serum
Platelets	At baseline	Platelets (cells/mm3) number in serum

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	At baseline	Total cholesterol (mg/dL) concentrations in serum
Insulin	At baseline	Insulin (mIU/L) concentration in serum
Thyroid hormones (FT3, FT4)	At baseline	FT3 (pg/mL), FT4 (pg/mL) concentration in serum
HDL cholesterol	At baseline	HDL cholesterol (mg/dL) concentrations in serum
eGFR (estimated glomerular filtration rate)	At baseline	eGFR (ml/min/1.73 mq)
Creatinin	At baseline	Creatinin (mg/dl) concentration in serum
BMI	At baseline	BMI (kg/m\^2)
TSH	At baseline	TSH (mU/L) concentration in serum
Weight	At baseline	Weight in kilograms
LDL cholesterol	At baseline	LDL cholesterol (mg/dL) concentrations in serum
Height	At baseline	Height in meters

Trial Locations

Locations (1)

National Institute of Gastroenterology IRCCS S. de Bellis; 🇮🇹 Castellana Grotte, Bari, Italy