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Trial record 1 of 2 for:    12588571 [PUBMED-IDS]
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Pilot Study: The Effect of Ergocalciferol on Plasma Mucin-1 Levels

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ClinicalTrials.gov Identifier: NCT03747523
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ergocalciferol Drug: Ergocalciferol Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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:
  • Drisdol
  • Calciferol
  • Calcidol
  • Vitamin D2

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:
  • Drisdol
  • Calciferol
  • Calcidol
  • Vitamin D2




Primary Outcome Measures :
  1. Plasma mucin-1 levels [ Time Frame: Baseline ]
    Plasma mucin-1 levels will be measured in both groups. using a two-tailed T-test.

  2. Plasma mucin-1 levels [ Time Frame: 4 days ]
    Plasma mucin-1 levels will be measured in both groups. using a two-tailed T-test.


Secondary Outcome Measures :
  1. Plasma mucin-1 levels [ Time Frame: 7 days ]
    Plasma mucin-1 levels will be measured in will be measured in both groups.

  2. Plasma mucin-1 levels [ Time Frame: 10 days ]
    Plasma mucin-1 levels will be measured in will be measured in both groups.

  3. Urinary mucin-1 levels in healthy controls [ Time Frame: Baseline ]
    Urinary mucin-1 levels

  4. Urinary mucin-1 levels in healthy controls [ Time Frame: 3 days ]
    Urinary mucin-1 levels

  5. Urinary mucin-1 levels in healthy controls [ Time Frame: 7 days ]
    Urinary mucin-1 levels

  6. Urinary mucin-1 levels in healthy controls [ Time Frame: 10 days ]
    Urinary mucin-1 levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747523


Contacts
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Contact: Kendrah Kidd, MS 336-716-7162 kkidd@wakehealth.edu
Contact: Vicki Robins, RN, BSN 336-716-4091 vrobins@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kendrah Kidd    336-716-7162    kkidd@wakehealth.edu   
Principal Investigator: Anthony J. Bleyer, MD, M.S         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Anthony J. Bleyer, MD, M.S Wake Forest University Health Sciences

Publications:
Bleyer AJ, Kmoch S: Autosomal Dominant Tubulointerstitial Kidney Disease, MUC1-Related. 1993

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03747523     History of Changes
Other Study ID Numbers: IRB00054784
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Wake Forest University Health Sciences:
Vitamin D Deficiency
Drisdol
Rickets
Plasma
Healthy Subjects
Autosomal Dominant Tubulo Interstitial Kidney Disease
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents