NCT04844164

Vitamin D Metabolism in Patients With Endocrine Disorders

Prospective Non-randomised Controlled Study of Vitamin D Metabolism in Patients With Endocrine Disorders (Acromegaly, Cushing's Disease, Primary Hyperparathyroidism, Diabetes Mellitus Type 1) Treated With Cholecalciferol Bolus Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Endocrinology Research Centre, Moscow · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Cholecalciferol 15000 UNT/ML Oral Solution	A single dose (150,000 IU) of cholecalciferol aqueous solution per os

Timeline

• Start date: 2019-04-16
• Primary completion: 2021-05-15
• Completion: 2021-06-01
• First posted: 2021-04-14
• Last updated: 2022-08-11

Locations

1 site across 1 country: Russia