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ObesityNCT04133441

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

An observational study of Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Obesity
How many people
341 participants
Where
1 siteItaly
Study dates
1 Jan 2019to 1 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Any kind of drug
  • Hypertension
  • Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
  • Chronic inflammatory diseases
  • Renal failure
  • Liver failure
Show all 10Show fewer
  • Angina pectoris
  • Myocardial infarction and heart failure
  • Genetic heart diseases
  • Thrombocytopenias

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • National Institute of Gastroenterology IRCCS S. de Bellis

    Castellana Grotte, Bari, 70013

Other trials in Italy

About this study

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

Read the 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.

Conditions
Obesity
Medical subject headings
Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vitamin D

    Vitamin D (ng/mL) concentration in serum

    Measured: At baseline

  2. Platelets

    Platelets (cells/mm3) number in serum

    Measured: At baseline

Secondary outcomes (11)

  1. Insulin

    Insulin (mIU/L) concentration in serum

    Measured: At baseline

  2. eGFR (estimated glomerular filtration rate)

    eGFR (ml/min/1.73 mq)

    Measured: At baseline

  3. Creatinin

    Creatinin (mg/dl) concentration in serum

    Measured: At baseline

  4. Total cholesterol

    Total cholesterol (mg/dL) concentrations in serum

    Measured: At baseline

  5. Thyroid hormones (FT3, FT4)

    FT3 (pg/mL), FT4 (pg/mL) concentration in serum

    Measured: At baseline

  6. HDL cholesterol

    HDL cholesterol (mg/dL) concentrations in serum

    Measured: At baseline

  7. LDL cholesterol

    LDL cholesterol (mg/dL) concentrations in serum

    Measured: At baseline

  8. TSH

    TSH (mU/L) concentration in serum

    Measured: At baseline

  9. BMI

    BMI (kg/m^2)

    Measured: At baseline

  10. Height

    Height in meters

    Measured: At baseline

  11. Weight

    Weight in kilograms

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start1 Jan 2019
  3. Primary completion1 Sep 2019
  4. Study completion1 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133441
Sponsor's protocol ID
vitDplatelet
Status last verified
Oct 2019
First submitted
18 Oct 2019
Last updated
21 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vitamin D (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.

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