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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133441
• Other study ID #: vitDplatelet
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2019
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Locations

Country	Name	City	State
Italy	National Institute of Gastroenterology IRCCS S. de Bellis	Castellana Grotte	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D	Vitamin D (ng/mL) concentration in serum	At baseline
Primary	Platelets	Platelets (cells/mm3) number in serum	At baseline
Secondary	Insulin	Insulin (mIU/L) concentration in serum	At baseline
Secondary	eGFR (estimated glomerular filtration rate)	eGFR (ml/min/1.73 mq)	At baseline
Secondary	Creatinin	Creatinin (mg/dl) concentration in serum	At baseline
Secondary	Total cholesterol	Total cholesterol (mg/dL) concentrations in serum	At baseline
Secondary	Thyroid hormones (FT3, FT4)	FT3 (pg/mL), FT4 (pg/mL) concentration in serum	At baseline
Secondary	HDL cholesterol	HDL cholesterol (mg/dL) concentrations in serum	At baseline
Secondary	LDL cholesterol	LDL cholesterol (mg/dL) concentrations in serum	At baseline
Secondary	TSH	TSH (mU/L) concentration in serum	At baseline
Secondary	BMI	BMI (kg/m^2)	At baseline
Secondary	Height	Height in meters	At baseline
Secondary	Weight	Weight in kilograms	At baseline