Vitamin D Metabolism in Patients With Endocrine Disorders

NCT04844164 | Completed Phase 1

• 2 other identifiers: ERC_2021/0119-15-00243
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary ACTH Hypersecretion; Acromegaly; Diabetes Mellitus, Type 1; Primary Hyperparathyroidism

Keywords

Vitamin D; Vitamin D deficiency; Chromatography, Liquid; Tandem Mass Spectrometry; Cholecalciferol

Outcome Measures

Primary Outcomes (2)

• Baseline 25(OH)D3 level

  Measured in ng\\mL.

  Day 0

• Change in 25(OH)D3 level

  Measured in ng\\mL.

  Day 1, 3, 7

Secondary Outcomes (18)

• Serum total calcium

  Day 0, 1, 3, 7

• Serum albumin-adjusted calcium

  Day 0, 1, 3, 7

• Serum phosphorus

  Day 0, 1, 3, 7

• Serum PTH

  Day 0, 1, 3, 7

• Serum creatinine

  Day 0, 1, 3, 7

Study Arms (5)

Cushing's Disease

EXPERIMENTAL

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Acromegaly

EXPERIMENTAL

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Diabetes Mellitus Type 1

EXPERIMENTAL

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Primary Hyperparathyroidism

EXPERIMENTAL

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Control group

EXPERIMENTAL

Drug: Cholecalciferol 15000 UNT/ML Oral Solution

Interventions

Cholecalciferol 15000 UNT/ML Oral Solution DRUG

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

Acromegaly; Control group; Cushing's Disease; Diabetes Mellitus Type 1; Primary Hyperparathyroidism

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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")

You may not qualify if:

• 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)

Sponsors & Collaborators

• Endocrinology Research Centre, Moscow: lead
• Russian Science Foundation: collaborator

Study Sites (1)

Endocrinology Research Centre, Moscow

Moscow, Russia

Location

Related Publications (2)

• 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.

  PMID: 33352890 BACKGROUND

• 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.

  PMID: 35138562 DERIVED

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion; Acromegaly; Diabetes Mellitus, Type 1; Hyperparathyroidism, Primary; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Hyperparathyroidism; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Officials

• Liudmila Rozhinskaya, MD, PhD

  Endocrinology Research Centre, Moscow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 14, 2021
• Study Start: April 16, 2019
• Primary Completion: May 15, 2021
• Study Completion: June 1, 2021
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)