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| ID | Type | Description | Link |
|---|---|---|---|
| 19-15-00243 | Other Grant/Funding Number | Russian Science Foundation |
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| Name | Class |
|---|---|
| Russian Science Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cushing's Disease | Experimental |
| |
| Acromegaly | Experimental |
| |
| Diabetes Mellitus Type 1 | Experimental |
| |
| Primary Hyperparathyroidism | Experimental |
| |
| Control group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol 15000 UNT/ML Oral Solution | Drug | A single dose (150,000 IU) of cholecalciferol aqueous solution per os |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline 25(OH)D3 level | Measured in ng\mL. | Day 0 |
| Change in 25(OH)D3 level | Measured in ng\mL. | Day 1, 3, 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum total calcium | Measured in mmol\L | Day 0, 1, 3, 7 |
| Serum albumin-adjusted calcium | Measured in mmol\L | Day 0, 1, 3, 7 |
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Inclusion Criteria:
Exclusion Criteria:
factors associated with vitamin D level
hypercalcemia or risk factors for hypercalcemia
allergy to vitamin D drugs
total 25(ОН)D >60 ng/ml (determined by chemiluminescent immunoanalysis)
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| Name | Affiliation | Role |
|---|---|---|
| Liudmila Rozhinskaya, MD, PhD | Endocrinology Research Centre, Moscow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology Research Centre, Moscow | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33352890 | Background | Povaliaeva A, Pigarova E, Zhukov A, Bogdanov V, Dzeranova L, Mel'nikova O, Pekareva E, Malysheva N, Ioutsi V, Nikankina L, Rozhinskaya L. Evaluation of Vitamin D Metabolism in Patients with Type 1 Diabetes Mellitus in the Setting of Cholecalciferol Treatment. Nutrients. 2020 Dec 18;12(12):3873. doi: 10.3390/nu12123873. | |
| 35138562 |
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| ID | Term |
|---|---|
| D047748 | Pituitary ACTH Hypersecretion |
| D000172 | Acromegaly |
| D003922 | Diabetes Mellitus, Type 1 |
| D049950 | Hyperparathyroidism, Primary |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
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| Serum phosphorus | Measured in mmol\L | Day 0, 1, 3, 7 |
| Serum PTH | Measured in pg/mL | Day 0, 1, 3, 7 |
| Serum creatinine | Measured in μmol/L | Day 0, 1, 3, 7 |
| Serum albumin | Measured in g/L | Day 0, 1, 3, 7 |
| Serum magnesium | Measured in mmol\L | Day 0, 1, 3, 7 |
| Calcium-creatinine ratio in spot urine | Measured in mmol/mmol | Day 0, 1, 3, 7 |
| Phosphorus-creatinine ratio in spot urine | Measured in mmol/mmol | Day 0, 1, 3, 7 |
| 1,25(OH)2D3 level | Measured in pg\mL. | Day 0, 1, 3, 7 |
| 24,25(OH)2D3 level | Measured in ng\mL. | Day 0, 1, 3, 7 |
| 3-epi-25(OH)D3 level | Measured in ng\mL. | Day 0, 1, 3, 7 |
| 25(OH)D2 level | Measured in ng\mL. | Day 0, 1, 3, 7 |
| D3 level | Measured in ng\mL. | Day 0, 1, 3, 7 |
| 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 | Measured in pg/mL | Day 0, 1, 3, 7 |
| Serum vitamin D-binding protein | Measured in mg/L | Day 0, 1, 3, 7 |
| Povaliaeva AA, Bogdanov VP, Zhukov AY, Pigarova EA, Dzeranova LK, Rozhinskaya LY, Mel'nichenko GA, Mokrysheva NG. Characterization of vitamin D metabolism in active acromegaly in the setting of bolus (150,000 IU) cholecalciferol treatment. Endocrine. 2022 May;76(2):407-418. doi: 10.1007/s12020-022-02994-0. Epub 2022 Feb 9. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |