Overview

Vitamin D Metabolism in Patients With Endocrine Disorders

Status:
Recruiting

Trial end date:
2021-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Endocrinology Research Centre, Moscow

Collaborator:

Russian Science Foundation

Treatments:

Cholecalciferol

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)