Vitamin D Metabolism in Patients With Endocrine Disorders

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844164
• Other study ID #: ERC_2021/01
• Secondary ID: 19-15-00243
• Status: Completed
• Phase: Phase 1
• Start date: April 16, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2022
• Source: Endocrinology Research Centre, Moscow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: June 1, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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(??)D >60 ng/ml (determined by chemiluminescent immunoanalysis)

Related Conditions & MeSH terms

• Acromegaly
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Endocrine System Diseases
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Pituitary ACTH Hypersecretion
• Primary Hyperparathyroidism

Intervention

Drug:
• Cholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os

Locations

Country	Name	City	State
Russian Federation	Endocrinology Research Centre, Moscow	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Endocrinology Research Centre, Moscow	Russian Science Foundation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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). pii: E3873. doi: 10.3390/nu12123873. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline 25(OH)D3 level	Measured in ng\mL.	Day 0
Primary	Change in 25(OH)D3 level	Measured in ng\mL.	Day 1, 3, 7
Secondary	Serum total calcium	Measured in mmol\L	Day 0, 1, 3, 7
Secondary	Serum albumin-adjusted calcium	Measured in mmol\L	Day 0, 1, 3, 7
Secondary	Serum phosphorus	Measured in mmol\L	Day 0, 1, 3, 7
Secondary	Serum PTH	Measured in pg/mL	Day 0, 1, 3, 7
Secondary	Serum creatinine	Measured in µmol/L	Day 0, 1, 3, 7
Secondary	Serum albumin	Measured in g/L	Day 0, 1, 3, 7
Secondary	Serum magnesium	Measured in mmol\L	Day 0, 1, 3, 7
Secondary	Calcium-creatinine ratio in spot urine	Measured in mmol/mmol	Day 0, 1, 3, 7
Secondary	Phosphorus-creatinine ratio in spot urine	Measured in mmol/mmol	Day 0, 1, 3, 7
Secondary	1,25(OH)2D3 level	Measured in pg\mL.	Day 0, 1, 3, 7
Secondary	24,25(OH)2D3 level	Measured in ng\mL.	Day 0, 1, 3, 7
Secondary	3-epi-25(OH)D3 level	Measured in ng\mL.	Day 0, 1, 3, 7
Secondary	25(OH)D2 level	Measured in ng\mL.	Day 0, 1, 3, 7
Secondary	D3 level	Measured in ng\mL.	Day 0, 1, 3, 7
Secondary	25(OH)D3/24,25(OH)2D3 ratio		Day 0, 1, 3, 7
Secondary	25(OH)D3/1,25(OH)2D3 ratio		Day 0, 1, 3, 7
Secondary	Serum free 25(OH)D	Measured in pg/mL	Day 0, 1, 3, 7
Secondary	Serum vitamin D-binding protein	Measured in mg/L	Day 0, 1, 3, 7