Clinical trial NCT04133441: 25-Hydroxyvitamin D Levels Are Negatively Associated With Platelets Number in a Cohort of Overweight and Obese Subjects
Official title: 25-Hydroxyvitamin D Levels Are Negatively Associated With Platelets Number in a Cohort of Overweight and Obese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 341
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D
timeFrame: At baseline
measure: Platelets
timeFrame: At baseline
Secondary outcomes:
measure: Insulin
timeFrame: At baseline
measure: eGFR (estimated glomerular filtration rate)
timeFrame: At baseline
measure: Creatinin
timeFrame: At baseline
measure: Total cholesterol
timeFrame: At baseline
measure: Thyroid hormones (FT3, FT4)
timeFrame: At baseline
measure: HDL cholesterol
timeFrame: At baseline
measure: LDL cholesterol
timeFrame: At baseline
measure: TSH
timeFrame: At baseline
measure: BMI
timeFrame: At baseline
measure: Height
timeFrame: At baseline
measure: Weight
timeFrame: At baseline
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: National Institute of Gastroenterology IRCCS S. de Bellis
state: Bari
Study officials:
References: