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Vitamin D Metabolism in Patients With Endocrine Disorders

NCT04844164 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2022-08-11

No results posted yet for this study

Summary

This prospective controlled interventional study aims to reveal the diversity of vitamin D metabolism in patients with certain endocrine disorders (Cushing's disease, acromegaly, primary hyperparathyroidism, diabetes mellitus type 1) compared to healthy adults. All patients will receive a single dose (150,000 IU) of cholecalciferol aqueous solution orally. Laboratory assessments including serum vitamin D metabolites (25(OH)D3, 25(OH)D2, 1,25(OH)2D3, 3-epi-25(OH)D3, 24,25(OH)2D3 and D3), free 25(OH)D, vitamin D-binding protein (DBP) and parathyroid hormone (PTH) as well as serum and urine biochemical parameters will be performed before the intake and on Days 1, 3 and 7 after the administration.

Conditions

  • Pituitary ACTH Hypersecretion
  • Acromegaly
  • Diabetes Mellitus, Type 1
  • Primary Hyperparathyroidism

Interventions

DRUG

Cholecalciferol 15000 UNT/ML Oral Solution

A single dose (150,000 IU) of cholecalciferol aqueous solution per os

Sponsors & Collaborators

  • Russian Science Foundation

    collaborator OTHER

  • Endocrinology Research Centre, Moscow

    lead OTHER_GOV

Principal Investigators

  • Liudmila Rozhinskaya, MD, PhD · Endocrinology Research Centre, Moscow

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2021-05-15
Completion
2021-06-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04844164 on ClinicalTrials.gov