Vitamin D Metabolism in Patients With Endocrine Disorders

NCT ID: NCT04844164

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2021-06-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cushing's Disease

Group Type: EXPERIMENTAL

Cholecalciferol 15000 UNT/ML Oral Solution

Intervention Type: DRUG

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

Acromegaly

Group Type: EXPERIMENTAL

Cholecalciferol 15000 UNT/ML Oral Solution

Intervention Type: DRUG

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

Diabetes Mellitus Type 1

Group Type: EXPERIMENTAL

Cholecalciferol 15000 UNT/ML Oral Solution

Intervention Type: DRUG

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

Primary Hyperparathyroidism

Group Type: EXPERIMENTAL

Cholecalciferol 15000 UNT/ML Oral Solution

Intervention Type: DRUG

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

Control group

Group Type: EXPERIMENTAL

Cholecalciferol 15000 UNT/ML Oral Solution

Intervention Type: DRUG

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

Interventions

Cholecalciferol 15000 UNT/ML Oral Solution

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Russian Science Foundation

OTHER

Sponsor Role: collaborator

Endocrinology Research Centre, Moscow

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liudmila Rozhinskaya, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology Research Centre, Moscow

Locations

Endocrinology Research Centre, Moscow

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: BACKGROUND

PMID: 33352890 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35138562 (View on PubMed)

Other Identifiers

19-15-00243

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ERC_2021/01

Identifier Type: -

Identifier Source: org_study_id