NCT04405141

Brief Summary

The investigators aimed to evaluate the relationship between LUTS and vitamin D with uroflowmetry parameters in female patients. They found no relation between vitamin D levels and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with urologic problems. The investigators believe that there is a need for studies emphasizing serum Ca levels in addition to vitamin D levels in patients with LUTS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

May 9, 2020

Last Update Submit

May 29, 2020

Conditions

Lower Urinary Tract SymptomsVitamin D DeficiencyCalcium Deficiency

Keywords

Lower Urinary Tract SymptomsVitamin D DeficiencyCalcium Deficiency

Outcome Measures

Primary Outcomes (1)

  • Uroflowmetry Results

    There was no significant relationship between age, creatinine, Qmax, Qav, V and vitamin D level (P\>0.05).

    12 months

Secondary Outcomes (1)

  • Vitamin D Levels

    12 months

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBecause females are more related to low urinary tract symptoms.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female patients with low urinary tract symptoms.

You may qualify if:

  • Clinical diagnosis of low urinary tract symptom

You may not qualify if:

  • Urinary tract infection, Diabetes mellitus, Neurological disorder, Pregnancy Stone disease Other urinary system disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lower Urinary Tract SymptomsVitamin D Deficiency

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
12 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 28, 2020

Study Start

January 1, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

June 1, 2020

Record last verified: 2020-05