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NCT Number: NCT04844164

Vitamin D Metabolism in Patients With Endocrine Disorders

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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Key information

Conditions

Pituitary ACTH Hypersecretion Acromegaly Autoimmune Diseases Avitaminosis Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Deficiency Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperparathyroidism Hyperparathyroidism, Primary Hyperpituitarism Hypothalamic Diseases Immune System Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pituitary Diseases Primary Hyperparathyroidism Vitamin D Deficiency

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Endocrinology Research Centre, Moscow

Moscow, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cholecalciferol 15000 UNT/ML Oral Solution

Drug

A single dose (150,000 IU) of cholecalciferol aqueous solution per os

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Endocrinology Research Centre, Moscow

Other Gov

Collaborators

  • Russian Science Foundation

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 14, 2021
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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