NCT04133441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

October 18, 2019

Last Update Submit

October 18, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Vitamin D

    Vitamin D (ng/mL) concentration in serum

    At baseline

  • Platelets

    Platelets (cells/mm3) number in serum

    At baseline

Secondary Outcomes (11)

  • Insulin

    At baseline

  • eGFR (estimated glomerular filtration rate)

    At baseline

  • Creatinin

    At baseline

  • Total cholesterol

    At baseline

  • Thyroid hormones (FT3, FT4)

    At baseline

  • +6 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 21, 2019

Study Start

January 1, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)