Pilot Study: The Effect of Ergocalciferol on Plasma Mucin-1 Levels

October 27, 2020 updated by: Wake Forest University Health Sciences

Study of the Effect of Ergocalciferol on Plasma and Urinary Mucin-1 Levels in Healthy Individuals and Individuals With Autosomal Dominant Tubulo-Interstitial Kidney Disease Due to MUC1 Mutations (ADTKD-MUC1)

To determine if a one-time oral administration of ergocalciferol results in a decline in plasma mucin-1 levels in healthy individuals and individuals with ADTKD-MUC1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pilot, open-labelled, to determine if oral administration of a single dose of ergocalciferol lowers plasma mucin-1 levels. The study population will include 40 healthy individuals and 40 individuals with ADTKD-MUC1.

The study consists of an initial screening, signing of consent of interested individuals, performance of pregnancy test in women of child-bearing age and screening labs, and administration of 200,000 units of ergocalciferol on Day 0 (On Study). Laboratory studies will be performed at baseline, on Days 3, 7, and 10.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Early 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

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

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

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years and <65 years
  • Females must be non-pregnant, non-lactating and fulfilling one of the following: a. Post menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments. b. Status post irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. c.

Use of acceptable contraceptive method: IUD with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system(e.g., NuvaRing®), a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives, sexual abstinence, or a sterile sexual partner.

  • Males must agree to avoid fathering a child (or donating sperm), and therefore be either sterile or agree to use, from the time of enrollment until 45 days after end of study, one of the following approved methods of contraception: a male condom with spermicide, a sterile sexual partner, use by female sexual partner of an IUD with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system (e.g.,NuvaRing®), a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives.
  • No serious health conditions except for estimated glomerular filtration rate <30 ml/min/1.73 m2 (according to the modified MDRD formula) in participants with ADTKD- MUC1.
  • Prior established genetic diagnosis of ADTKD-MUC1 in participants recruited with ADTKD-MUC1.
  • Able to understand and comply with requirements of the entire study and to communicate with the study team.
  • Living in close enough proximity to a local laboratory to obtain labwork for the study.
  • Written informed consent using a document that has been approved by the Institutional Review Board.
  • The participant has not taken ergocalciferol in the month prior to study initiation. If receiving cholecalciferol, the dose is < 1000/day and has been stopped one month prior to Day 0 (On Study).
  • Participants agree NOT to take ergocalciferol or cholecalciferol (except for<500 IU that contained in a daily multi-vitamin) for six months after receiving the one-time dose of ergocalciferol.

Exclusion Criteria:

  • Major systemic illness other than chronic kidney disease in individuals with ADTKD- MUC1.
  • A history of granulomatous disorders (sarcoidosis, tuberculosis), hyperparathyroidism, or other disorders of calcium metabolism.
  • A history of nephrolithiasis.
  • A history of osteoporosis or osteopenia.
  • A fracture or a fall that did not occur during exercise within the last six months.
  • Intolerance or known allergic reaction to ergocalciferol.
  • 25 hydroxy Vitamin D level > upper limit of normal.
  • Lactating.
  • Liver disease.
  • Receiving glucocorticoids.

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: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy Group
40 Healthy individuals will receive a single dose of ergocalciferol (200,000 units)
Drug: Ergocalciferol
Investigational drug will be administered to eligible participants in a single dose of 200,000 USP units vitamin D
Other Names:
  • Vitamin D2
  • Calciferol
  • Calcidol
  • Drisdol
EXPERIMENTAL: ADTKD-MUC1 Group
40 individuals with ADTKD-MUC1 (Autosomal Dominant Tubulo-Interstitial Kidney Disease- a rare disease caused by mutation in MUC1) will receive a single dose of ergocalciferol (200,000 units)
Drug: Ergocalciferol
Investigational drug will be administered to eligible participants in a single dose of 200,000 USP units vitamin D
Other Names:
  • Vitamin D2
  • Calciferol
  • Calcidol
  • Drisdol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma mucin-1 levels
Time Frame: Baseline
Plasma mucin-1 levels will be measured in both groups. using a two-tailed T-test.
Baseline
Plasma mucin-1 levels
Time Frame: 3 days
Plasma mucin-1 levels will be measured in both groups. using a two-tailed T-test.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma mucin-1 levels
Time Frame: 7 days
Plasma mucin-1 levels will be measured in will be measured in both groups.
7 days
Plasma mucin-1 levels
Time Frame: 10 days
Plasma mucin-1 levels will be measured in will be measured in both groups.
10 days
Urinary mucin-1 levels in healthy controls
Time Frame: Baseline
Urinary mucin-1 levels
Baseline
Urinary mucin-1 levels in healthy controls
Time Frame: 3 days
Urinary mucin-1 levels
3 days
Urinary mucin-1 levels in healthy controls
Time Frame: 7 days
Urinary mucin-1 levels
7 days
Urinary mucin-1 levels in healthy controls
Time Frame: 10 days
Urinary mucin-1 levels
10 days

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Anthony J. Bleyer, MD, M.S, Wake Forest University Health Sciences

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)

March 12, 2019

Primary Completion (ACTUAL)

December 20, 2019

Study Completion (ACTUAL)

January 27, 2020

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (ACTUAL)

November 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00054784

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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