A Phase 1 interventional study of Cholecalciferol 15000 UNT/ML Oral Solution in Pituitary ACTH Hypersecretion, Acromegaly and Diabetes Mellitus, Type 1, sponsored by Endocrinology Research Centre, Moscow. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Endocrinology Research Centre, Moscow · Phase 1, Interventional, and Basic science
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.
64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.
This study's enrollment of 261 is above the median of 44 across 40 interventional studies indexed under Pituitary ACTH Hypersecretion.
Browse Pituitary ACTH Hypersecretion studies →Endocrinology Research Centre, Moscow is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
factors associated with vitamin D level
hypercalcemia or risk factors for hypercalcemia
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cholecalciferol 15000 UNT/ML Oral Solution
Drug: Cholecalciferol 15000 UNT/ML Oral Solution
Drug: Cholecalciferol 15000 UNT/ML Oral Solution
Drug: Cholecalciferol 15000 UNT/ML Oral Solution
Drug: Cholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
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
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Pituitary ACTH Hypersecretion →
Endocrinology Research Centre, Moscow