search
Back to results

Vitamin D Metabolism in Patients With Endocrine Disorders

Primary Purpose

Pituitary ACTH Hypersecretion, Acromegaly, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Cholecalciferol 15000 UNT/ML Oral Solution
Sponsored by
Endocrinology Research Centre, Moscow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pituitary ACTH Hypersecretion focused on measuring Vitamin D, Vitamin D deficiency, Chromatography, Liquid, Tandem Mass Spectrometry, Cholecalciferol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Endocrinology Research Centre, Moscow

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cushing's Disease

Acromegaly

Diabetes Mellitus Type 1

Primary Hyperparathyroidism

Control group

Arm Description

Outcomes

Primary Outcome Measures

Baseline 25(OH)D3 level
Measured in ng\mL.
Change in 25(OH)D3 level
Measured in ng\mL.

Secondary Outcome Measures

Serum total calcium
Measured in mmol\L
Serum albumin-adjusted calcium
Measured in mmol\L
Serum phosphorus
Measured in mmol\L
Serum PTH
Measured in pg/mL
Serum creatinine
Measured in μmol/L
Serum albumin
Measured in g/L
Serum magnesium
Measured in mmol\L
Calcium-creatinine ratio in spot urine
Measured in mmol/mmol
Phosphorus-creatinine ratio in spot urine
Measured in mmol/mmol
1,25(OH)2D3 level
Measured in pg\mL.
24,25(OH)2D3 level
Measured in ng\mL.
3-epi-25(OH)D3 level
Measured in ng\mL.
25(OH)D2 level
Measured in ng\mL.
D3 level
Measured in ng\mL.
25(OH)D3/24,25(OH)2D3 ratio
25(OH)D3/1,25(OH)2D3 ratio
Serum free 25(OH)D
Measured in pg/mL
Serum vitamin D-binding protein
Measured in mg/L

Full Information

First Posted
April 9, 2021
Last Updated
August 10, 2022
Sponsor
Endocrinology Research Centre, Moscow
Collaborators
Russian Science Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04844164
Brief Title
Vitamin D Metabolism in Patients With Endocrine Disorders
Official Title
Prospective Non-randomised Controlled Study of Vitamin D Metabolism in Patients With Endocrine Disorders (Acromegaly, Cushing's Disease, Primary Hyperparathyroidism, Diabetes Mellitus Type 1) Treated With Cholecalciferol Bolus Dose
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endocrinology Research Centre, Moscow
Collaborators
Russian Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary ACTH Hypersecretion, Acromegaly, Diabetes Mellitus, Type 1, Primary Hyperparathyroidism
Keywords
Vitamin D, Vitamin D deficiency, Chromatography, Liquid, Tandem Mass Spectrometry, Cholecalciferol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cushing's Disease
Arm Type
Experimental
Arm Title
Acromegaly
Arm Type
Experimental
Arm Title
Diabetes Mellitus Type 1
Arm Type
Experimental
Arm Title
Primary Hyperparathyroidism
Arm Type
Experimental
Arm Title
Control group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol 15000 UNT/ML Oral Solution
Intervention Description
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
Primary Outcome Measure Information:
Title
Baseline 25(OH)D3 level
Description
Measured in ng\mL.
Time Frame
Day 0
Title
Change in 25(OH)D3 level
Description
Measured in ng\mL.
Time Frame
Day 1, 3, 7
Secondary Outcome Measure Information:
Title
Serum total calcium
Description
Measured in mmol\L
Time Frame
Day 0, 1, 3, 7
Title
Serum albumin-adjusted calcium
Description
Measured in mmol\L
Time Frame
Day 0, 1, 3, 7
Title
Serum phosphorus
Description
Measured in mmol\L
Time Frame
Day 0, 1, 3, 7
Title
Serum PTH
Description
Measured in pg/mL
Time Frame
Day 0, 1, 3, 7
Title
Serum creatinine
Description
Measured in μmol/L
Time Frame
Day 0, 1, 3, 7
Title
Serum albumin
Description
Measured in g/L
Time Frame
Day 0, 1, 3, 7
Title
Serum magnesium
Description
Measured in mmol\L
Time Frame
Day 0, 1, 3, 7
Title
Calcium-creatinine ratio in spot urine
Description
Measured in mmol/mmol
Time Frame
Day 0, 1, 3, 7
Title
Phosphorus-creatinine ratio in spot urine
Description
Measured in mmol/mmol
Time Frame
Day 0, 1, 3, 7
Title
1,25(OH)2D3 level
Description
Measured in pg\mL.
Time Frame
Day 0, 1, 3, 7
Title
24,25(OH)2D3 level
Description
Measured in ng\mL.
Time Frame
Day 0, 1, 3, 7
Title
3-epi-25(OH)D3 level
Description
Measured in ng\mL.
Time Frame
Day 0, 1, 3, 7
Title
25(OH)D2 level
Description
Measured in ng\mL.
Time Frame
Day 0, 1, 3, 7
Title
D3 level
Description
Measured in ng\mL.
Time Frame
Day 0, 1, 3, 7
Title
25(OH)D3/24,25(OH)2D3 ratio
Time Frame
Day 0, 1, 3, 7
Title
25(OH)D3/1,25(OH)2D3 ratio
Time Frame
Day 0, 1, 3, 7
Title
Serum free 25(OH)D
Description
Measured in pg/mL
Time Frame
Day 0, 1, 3, 7
Title
Serum vitamin D-binding protein
Description
Measured in mg/L
Time Frame
Day 0, 1, 3, 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liudmila Rozhinskaya, MD, PhD
Organizational Affiliation
Endocrinology Research Centre, Moscow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology Research Centre, Moscow
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33352890
Citation
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.
Results Reference
background
PubMed Identifier
35138562
Citation
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.
Results Reference
derived

Learn more about this trial

Vitamin D Metabolism in Patients With Endocrine Disorders

We'll reach out to this number within 24 hrs