Acromegaly, Diabetes Mellitus, Type 1, Pituitary ACTH Hypersecretion, Primary Hyperparathyroidism
Conditions
Keywords
Vitamin D, Vitamin D deficiency, Chromatography, Liquid, Tandem Mass Spectrometry, Cholecalciferol
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.
Interventions
DRUGCholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
Sponsors
Russian Science Foundation
Endocrinology Research Centre, Moscow
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline 25(OH)D3 level | Day 0 | Measured in ng\\mL. |
| Change in 25(OH)D3 level | Day 1, 3, 7 | Measured in ng\\mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum phosphorus | Day 0, 1, 3, 7 | Measured in mmol\\L |
| Serum PTH | Day 0, 1, 3, 7 | Measured in pg/mL |
| Serum creatinine | Day 0, 1, 3, 7 | Measured in μmol/L |
| Serum albumin | Day 0, 1, 3, 7 | Measured in g/L |
| Serum magnesium | Day 0, 1, 3, 7 | Measured in mmol\\L |
| Calcium-creatinine ratio in spot urine | Day 0, 1, 3, 7 | Measured in mmol/mmol |
| Phosphorus-creatinine ratio in spot urine | Day 0, 1, 3, 7 | Measured in mmol/mmol |
| 1,25(OH)2D3 level | Day 0, 1, 3, 7 | Measured in pg\\mL. |
| Serum total calcium | Day 0, 1, 3, 7 | Measured in mmol\\L |
| 3-epi-25(OH)D3 level | Day 0, 1, 3, 7 | Measured in ng\\mL. |
| 25(OH)D2 level | Day 0, 1, 3, 7 | Measured in ng\\mL. |
| D3 level | Day 0, 1, 3, 7 | Measured in ng\\mL. |
| 25(OH)D3/24,25(OH)2D3 ratio | Day 0, 1, 3, 7 | — |
| 25(OH)D3/1,25(OH)2D3 ratio | Day 0, 1, 3, 7 | — |
| Serum free 25(OH)D | Day 0, 1, 3, 7 | Measured in pg/mL |
| Serum vitamin D-binding protein | Day 0, 1, 3, 7 | Measured in mg/L |
| 24,25(OH)2D3 level | Day 0, 1, 3, 7 | Measured in ng\\mL. |
| Serum albumin-adjusted calcium | Day 0, 1, 3, 7 | Measured in mmol\\L |
Countries
Russia
Outcome results
None listed