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Pituitary ACTH HypersecretionPhase 1NCT04844164

Vitamin D Metabolism in Patients With Endocrine Disorders

A Phase 1 study testing Cholecalciferol 15000 UNT/ML Oral Solution in people with Pituitary ACTH Hypersecretion and Acromegaly, run by Endocrinology Research Centre, Moscow at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Cholecalciferol 15000 UNT/ML Oral Solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
1 siteRussia
Study dates
16 Apr 2019to 1 Jun 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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")

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Endocrinology Research Centre, Moscow

    Moscow

Other trials in Russia

About this study

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

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.

Being tested
Cholecalciferol 15000 UNT/ML Oral Solution
Keywords
Vitamin D, Vitamin D deficiency, Chromatography, Liquid, Tandem Mass Spectrometry, Cholecalciferol
Medical subject headings
Pituitary ACTH Hypersecretion, Acromegaly, Diabetes Mellitus, Type 1, Hyperparathyroidism, Primary, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cholecalciferol 15000 UNT/ML Oral SolutionDrug

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

Study groups in NCT04844164
Study groupRoleWhat they receive
Cushing's DiseaseExperimentalNot described
Receives: Drug: Cholecalciferol 15000 UNT/ML Oral Solution
AcromegalyExperimentalNot described
Receives: Drug: Cholecalciferol 15000 UNT/ML Oral Solution
Diabetes Mellitus Type 1ExperimentalNot described
Receives: Drug: Cholecalciferol 15000 UNT/ML Oral Solution
Primary HyperparathyroidismExperimentalNot described
Receives: Drug: Cholecalciferol 15000 UNT/ML Oral Solution
Control groupExperimentalNot described
Receives: Drug: Cholecalciferol 15000 UNT/ML Oral Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline 25(OH)D3 level

    Measured in ng\mL.

    Measured: Day 0

  2. Change in 25(OH)D3 level

    Measured in ng\mL.

    Measured: Day 1, 3, 7

Secondary outcomes (18)

  1. Serum total calcium

    Measured in mmol\L

    Measured: Day 0, 1, 3, 7

  2. Serum albumin-adjusted calcium

    Measured in mmol\L

    Measured: Day 0, 1, 3, 7

  3. Serum phosphorus

    Measured in mmol\L

    Measured: Day 0, 1, 3, 7

  4. Serum PTH

    Measured in pg/mL

    Measured: Day 0, 1, 3, 7

  5. Serum creatinine

    Measured in μmol/L

    Measured: Day 0, 1, 3, 7

  6. Serum albumin

    Measured in g/L

    Measured: Day 0, 1, 3, 7

  7. Serum magnesium

    Measured in mmol\L

    Measured: Day 0, 1, 3, 7

  8. Calcium-creatinine ratio in spot urine

    Measured in mmol/mmol

    Measured: Day 0, 1, 3, 7

  9. Phosphorus-creatinine ratio in spot urine

    Measured in mmol/mmol

    Measured: Day 0, 1, 3, 7

  10. 1,25(OH)2D3 level

    Measured in pg\mL.

    Measured: Day 0, 1, 3, 7

  11. 24,25(OH)2D3 level

    Measured in ng\mL.

    Measured: Day 0, 1, 3, 7

  12. 3-epi-25(OH)D3 level

    Measured in ng\mL.

    Measured: Day 0, 1, 3, 7

  13. 25(OH)D2 level

    Measured in ng\mL.

    Measured: Day 0, 1, 3, 7

  14. D3 level

    Measured in ng\mL.

    Measured: Day 0, 1, 3, 7

  15. 25(OH)D3/24,25(OH)2D3 ratio

    Measured: Day 0, 1, 3, 7

  16. 25(OH)D3/1,25(OH)2D3 ratio

    Measured: Day 0, 1, 3, 7

  17. Serum free 25(OH)D

    Measured in pg/mL

    Measured: Day 0, 1, 3, 7

  18. Serum vitamin D-binding protein

    Measured in mg/L

    Measured: Day 0, 1, 3, 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start16 Apr 2019
  3. Primary completion15 May 2021
  4. Study completion1 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844164
Sponsor's protocol ID
ERC_2021/01
Other IDs
19-15-00243
Status last verified
Aug 2022
First submitted
9 Apr 2021
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33352890

  • 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.

    PubMed 35138562

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cholecalciferol 15000 UNT/ML Oral Solution in people with Pituitary ACTH Hypersecretion and Acromegaly, run by Endocrinology Research Centre, Moscow at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline 25(OH)D3 level (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844164, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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