NCT05716750

Brief Summary

Evaluation of the change of serum Prolidase and Leptin values in the diagnosis and follow-up of osteomalacia and its clinical usability

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

January 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

January 9, 2023

Last Update Submit

February 10, 2023

Conditions

Osteomalacia

Outcome Measures

Primary Outcomes (2)

  • Serum Prolidase activity

    Prolidase activity

    8 weeks

  • Serum Leptin

    Leptin

    8 weeks

Study Arms (1)

Osteomalasia

OTHER

Our study, which is the only group planned prospectively, aims to compare clinical and laboratory data and serum prolidase activity and leptin levels in 38 patients diagnosed with osteomalacia after and before 8 weeks of 50,000 IU D vit treatment.

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

50,000 IU vit D treatment for 8 weeks

Also known as: vit D treatment
Osteomalasia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Among the patients who applied to the outpatient clinic, those with clinical complaints of osteomalacia (diffuse pain, fatigue, rapid fatigue, proximal extremity weakness, etc.)
  • H vit. D level of 10ng/ml and below

You may not qualify if:

  • Other metabolic and endocrine bone diseases (secondary osteoporosis, paget hast, osteogenesis imperfecta, osteomyelitis etc.)
  • Patients who have previously received treatment for low vitamin d
  • Those with low vitamin D levels due to liver or kidney failure
  • Those who receive treatment for tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteomalacia

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

RicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assist. prof. dr

Study Record Dates

First Submitted

January 9, 2023

First Posted

February 8, 2023

Study Start

February 15, 2023

Primary Completion

April 30, 2023

Study Completion

June 30, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share