Vitamin D Metabolism in Patients With Endocrine Disorders

August 10, 2022 updated by: Endocrinology Research Centre, Moscow

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
261

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control group
Drug: Cholecalciferol 15000 UNT/ML Oral Solution
A single dose (150,000 IU) of cholecalciferol aqueous solution per os
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline 25(OH)D3 level
Time Frame: Day 0
Measured in ng\mL.
Day 0
Change in 25(OH)D3 level
Time Frame: Day 1, 3, 7
Measured in ng\mL.
Day 1, 3, 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum total calcium
Time Frame: Day 0, 1, 3, 7
Measured in mmol\L
Day 0, 1, 3, 7
Serum albumin-adjusted calcium
Time Frame: Day 0, 1, 3, 7
Measured in mmol\L
Day 0, 1, 3, 7
Serum phosphorus
Time Frame: Day 0, 1, 3, 7
Measured in mmol\L
Day 0, 1, 3, 7
Serum PTH
Time Frame: Day 0, 1, 3, 7
Measured in pg/mL
Day 0, 1, 3, 7
Serum creatinine
Time Frame: Day 0, 1, 3, 7
Measured in μmol/L
Day 0, 1, 3, 7
Serum albumin
Time Frame: Day 0, 1, 3, 7
Measured in g/L
Day 0, 1, 3, 7
Serum magnesium
Time Frame: Day 0, 1, 3, 7
Measured in mmol\L
Day 0, 1, 3, 7
Calcium-creatinine ratio in spot urine
Time Frame: Day 0, 1, 3, 7
Measured in mmol/mmol
Day 0, 1, 3, 7
Phosphorus-creatinine ratio in spot urine
Time Frame: Day 0, 1, 3, 7
Measured in mmol/mmol
Day 0, 1, 3, 7
1,25(OH)2D3 level
Time Frame: Day 0, 1, 3, 7
Measured in pg\mL.
Day 0, 1, 3, 7
24,25(OH)2D3 level
Time Frame: Day 0, 1, 3, 7
Measured in ng\mL.
Day 0, 1, 3, 7
3-epi-25(OH)D3 level
Time Frame: Day 0, 1, 3, 7
Measured in ng\mL.
Day 0, 1, 3, 7
25(OH)D2 level
Time Frame: Day 0, 1, 3, 7
Measured in ng\mL.
Day 0, 1, 3, 7
D3 level
Time Frame: Day 0, 1, 3, 7
Measured in ng\mL.
Day 0, 1, 3, 7
25(OH)D3/24,25(OH)2D3 ratio
Time Frame: Day 0, 1, 3, 7
Day 0, 1, 3, 7
25(OH)D3/1,25(OH)2D3 ratio
Time Frame: Day 0, 1, 3, 7
Day 0, 1, 3, 7
Serum free 25(OH)D
Time Frame: Day 0, 1, 3, 7
Measured in pg/mL
Day 0, 1, 3, 7
Serum vitamin D-binding protein
Time Frame: Day 0, 1, 3, 7
Measured in mg/L
Day 0, 1, 3, 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endocrinology Research Centre, Moscow

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Russian Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liudmila Rozhinskaya, MD, PhD, Endocrinology Research Centre, Moscow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERC_2021/01
  • 19-15-00243 (Other Grant/Funding Number: Russian Science Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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