Status:
COMPLETED
Vitamin D Metabolism in Patients With Endocrine Disorders
Lead Sponsor:
Endocrinology Research Centre, Moscow
Collaborating Sponsors:
Russian Science Foundation
Conditions:
Pituitary ACTH Hypersecretion
Acromegaly
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 hyperparathyr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT04844164
Start Date
April 16 2019
End Date
June 1 2021
Last Update
August 11 2022
Active Locations (1)
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1
Endocrinology Research Centre, Moscow
Moscow, Russia