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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
261
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
Endocrinology Research Centre, Moscow
Moscow, Russia
Baseline 25(OH)D3 level
Measured in ng\\mL.
Time frame: Day 0
Change in 25(OH)D3 level
Measured in ng\\mL.
Time frame: Day 1, 3, 7
Serum total calcium
Measured in mmol\\L
Time frame: Day 0, 1, 3, 7
Serum albumin-adjusted calcium
Measured in mmol\\L
Time frame: Day 0, 1, 3, 7
Serum phosphorus
Measured in mmol\\L
Time frame: Day 0, 1, 3, 7
Serum PTH
Measured in pg/mL
Time frame: Day 0, 1, 3, 7
Serum creatinine
Measured in μmol/L
Time frame: Day 0, 1, 3, 7
Serum albumin
Measured in g/L
Time frame: Day 0, 1, 3, 7
Serum magnesium
Measured in mmol\\L
Time frame: Day 0, 1, 3, 7
Calcium-creatinine ratio in spot urine
Measured in mmol/mmol
Time frame: Day 0, 1, 3, 7
Phosphorus-creatinine ratio in spot urine
Measured in mmol/mmol
Time frame: Day 0, 1, 3, 7
1,25(OH)2D3 level
Measured in pg\\mL.
Time frame: Day 0, 1, 3, 7
24,25(OH)2D3 level
Measured in ng\\mL.
Time frame: Day 0, 1, 3, 7
3-epi-25(OH)D3 level
Measured in ng\\mL.
Time frame: Day 0, 1, 3, 7
25(OH)D2 level
Measured in ng\\mL.
Time frame: Day 0, 1, 3, 7
D3 level
Measured in ng\\mL.
Time frame: Day 0, 1, 3, 7
25(OH)D3/24,25(OH)2D3 ratio
Time frame: Day 0, 1, 3, 7
25(OH)D3/1,25(OH)2D3 ratio
Time frame: Day 0, 1, 3, 7
Serum free 25(OH)D
Measured in pg/mL
Time frame: Day 0, 1, 3, 7
Serum vitamin D-binding protein
Measured in mg/L
Time frame: Day 0, 1, 3, 7
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