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

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ClinicalTrials.gov Identifier: NCT04133441
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Gianluigi Giannelli, 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.

Condition or disease
Obesity

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.

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Study Type : Observational
Actual Enrollment : 341 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 25-Hydroxyvitamin D Levels Are Negatively Associated With Platelets Number in a Cohort of Overweight and Obese Subjects
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Calcifediol




Primary Outcome Measures :
  1. Vitamin D [ Time Frame: At baseline ]
    Vitamin D (ng/mL) concentration in serum

  2. Platelets [ Time Frame: At baseline ]
    Platelets (cells/mm3) number in serum


Secondary Outcome Measures :
  1. Insulin [ Time Frame: At baseline ]
    Insulin (mIU/L) concentration in serum

  2. eGFR (estimated glomerular filtration rate) [ Time Frame: At baseline ]
    eGFR (ml/min/1.73 mq)

  3. Creatinin [ Time Frame: At baseline ]
    Creatinin (mg/dl) concentration in serum

  4. Total cholesterol [ Time Frame: At baseline ]
    Total cholesterol (mg/dL) concentrations in serum

  5. Thyroid hormones (FT3, FT4) [ Time Frame: At baseline ]
    FT3 (pg/mL), FT4 (pg/mL) concentration in serum

  6. HDL cholesterol [ Time Frame: At baseline ]
    HDL cholesterol (mg/dL) concentrations in serum

  7. LDL cholesterol [ Time Frame: At baseline ]
    LDL cholesterol (mg/dL) concentrations in serum

  8. TSH [ Time Frame: At baseline ]
    TSH (mU/L) concentration in serum

  9. BMI [ Time Frame: At baseline ]
    BMI (kg/m^2)

  10. Height [ Time Frame: At baseline ]
    Height in meters

  11. Weight [ Time Frame: At baseline ]
    Weight in kilograms



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133441


Locations
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Italy
National Institute of Gastroenterology IRCCS S. de Bellis
Castellana Grotte, Bari, Italy, 70013
Sponsors and Collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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Responsible Party: Gianluigi Giannelli, Clinical Professor, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier: NCT04133441     History of Changes
Other Study ID Numbers: vitDplatelet
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents