Brief Title
Vitamin D Metabolism in Patients With Endocrine Disorders
Official Title
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
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Baseline 25(OH)D3 level
Secondary Outcome
Serum total calcium
Condition
Pituitary ACTH Hypersecretion
Intervention
Cholecalciferol 15000 UNT/ML Oral Solution
Study Arms / Comparison Groups
Cushing's Disease
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
261
Start Date
April 16, 2019
Completion Date
June 1, 2021
Primary Completion Date
May 15, 2021
Eligibility Criteria
Inclusion Criteria: - confirmed diagnosis (arms "Cushing's Disease", "Acromegaly", "Diabetes Mellitus Type 1", "Primary Hyperparathyroidism") - active phase of the disease (arms "Cushing's Disease", "Acromegaly") - no history of surgical and specific pharmacological treatment (arm "Primary Hyperparathyroidism") - HbA1c <8.0% (arm "Diabetes Mellitus Type 1") - absence of the specified endocrine disorders (arm "Control group") Exclusion Criteria: - factors associated with vitamin D level - intake of the following drugs during the 3 months preceding the study: vitamin D medications; glucocorticosteroids; antiretroviral drugs; antifungal drugs; cholestyramine, orlistat; antiepileptic drugs; antidepressants (fluoxetine); diuretics (spironolactone); antimicrobial agents (macrolides, tetracyclines, isoniazid, rifampin, primaquine); chemotherapy (cyclophosphamide, tamoxifen, paclitaxel, ifosfamide, irinotecan, etoposide, vinblastine); immunosuppressants (cyclosporin A, tacrolimus, sirolimus); H2 receptor antagonists. - BMI >35 kg/m2 - pregnancy - granulomatous disease (sarcoidosis, tuberculosis, histoplasmosis, berylliosis, coccidiomycosis) - disease with malabsorption syndrome (Crohn's disease, ulcerative colitis, celiac disease, post-bariatric surgery condition, decompensation of chronic pancreatitis) - reduced renal function (eGFR <60 ml/min/1.73m2) - laboratory signs of liver failure (hypoalbuminemia, hypoprothrombinemia) - hypercalcemia or risk factors for hypercalcemia - serum total calcium >3.0 mmol/L - myeloma - immobilization - thiazide diuretics intake - allergy to vitamin D drugs - total 25(ОН)D >60 ng/ml (determined by chemiluminescent immunoanalysis)
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Liudmila Rozhinskaya, MD, PhD, ,
Location Countries
Russian Federation
Location Countries
Russian Federation
Administrative Informations
NCT ID
NCT04844164
Organization ID
ERC_2021/01
Secondary IDs
19-15-00243
Responsible Party
Sponsor
Study Sponsor
Endocrinology Research Centre, Moscow
Collaborators
Russian Science Foundation
Study Sponsor
Liudmila Rozhinskaya, MD, PhD, Principal Investigator, Endocrinology Research Centre, Moscow
Verification Date
August 2022