Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Metabolism in Patients With Endocrine Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04844164
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Russian Science Foundation
Information provided by (Responsible Party):
Endocrinology Research Centre, Moscow

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pituitary ACTH Hypersecretion Acromegaly Diabetes Mellitus, Type 1 Primary Hyperparathyroidism Drug: Cholecalciferol 15000 UNT/ML Oral Solution Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cushing's Disease Drug: Cholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
Experimental: Acromegaly Drug: Cholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
Experimental: Diabetes Mellitus Type 1 Drug: Cholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
Experimental: Primary Hyperparathyroidism Drug: Cholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
Experimental: Control group Drug: Cholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Baseline 25(OH)D3 level [ Time Frame: Day 0 ]
    Measured in ng\mL.

  2. Change in 25(OH)D3 level [ Time Frame: Day 1, 3, 7 ]
    Measured in ng\mL.


Secondary Outcome Measures :
  1. Serum total calcium [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in mmol\L

  2. Serum albumin-adjusted calcium [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in mmol\L

  3. Serum phosphorus [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in mmol\L

  4. Serum PTH [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in pg/mL

  5. Serum creatinine [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in μmol/L

  6. Serum albumin [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in g/L

  7. Serum magnesium [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in mmol\L

  8. Calcium-creatinine ratio in spot urine [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in mmol/mmol

  9. Phosphorus-creatinine ratio in spot urine [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in mmol/mmol

  10. 1,25(OH)2D3 level [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in pg\mL.

  11. 24,25(OH)2D3 level [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in ng\mL.

  12. 3-epi-25(OH)D3 level [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in ng\mL.

  13. 25(OH)D2 level [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in ng\mL.

  14. D3 level [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in ng\mL.

  15. 25(OH)D3/24,25(OH)2D3 ratio [ Time Frame: Day 0, 1, 3, 7 ]
  16. 25(OH)D3/1,25(OH)2D3 ratio [ Time Frame: Day 0, 1, 3, 7 ]
  17. Serum free 25(OH)D [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in pg/mL

  18. Serum vitamin D-binding protein [ Time Frame: Day 0, 1, 3, 7 ]
    Measured in mg/L


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844164


Contacts
Layout table for location contacts
Contact: Alexandra Povaliaeva, MD +74991243422 ext 9297 povalyaeva.alexandra@endocrincentr.ru
Contact: Artem Zhukov, MD +74991243422 ext 3339 jukov.artem@endocrincentr.ru

Locations
Layout table for location information
Russian Federation
Endocrinology Research Centre, Moscow Recruiting
Moscow, Russian Federation
Contact: Alexandra Povaliaeva, MD    +74991243422 ext 9297    povalyaeva.alexandra@endocrincentr.ru   
Sponsors and Collaborators
Endocrinology Research Centre, Moscow
Russian Science Foundation
Investigators
Layout table for investigator information
Principal Investigator: Liudmila Rozhinskaya, MD, PhD Endocrinology Research Centre, Moscow
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Endocrinology Research Centre, Moscow
ClinicalTrials.gov Identifier: NCT04844164    
Other Study ID Numbers: ERC_2021/01
19-15-00243 ( Other Grant/Funding Number: Russian Science Foundation )
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Endocrinology Research Centre, Moscow:
Vitamin D
Vitamin D deficiency
Chromatography, Liquid
Tandem Mass Spectrometry
Cholecalciferol
Additional relevant MeSH terms:
Layout table for MeSH terms
Acromegaly
Pituitary ACTH Hypersecretion
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperparathyroidism
Hyperparathyroidism, Primary
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Parathyroid Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents