Vitamin D Metabolism in Patients With Endocrine Disorders

Endocrinology Research Centre, Moscow

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Pituitary ACTH Hypersecretion; Primary Hyperparathyroidism; Acromegaly

Treatments: Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04844164

ERC_2021/01

19-15-00243 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 261 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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261 participants in 5 patient groups

Cushing's Disease

Experimental group

Treatment:

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Acromegaly

Experimental group

Treatment:

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Diabetes Mellitus Type 1

Experimental group

Treatment:

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Primary Hyperparathyroidism

Experimental group

Treatment:

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Control group

Experimental group

Treatment:

Drug: Cholecalciferol 15000 UNT/ML Oral Solution