Pilot Study: The Effect of Ergocalciferol on Plasma Mucin-1 Levels
NCT ID: NCT03747523
Last Updated: 2020-10-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
EARLY_PHASE1
Total Enrollment
44 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-12
Study Completion Date
2020-01-27
Brief Summary
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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.
Detailed Description
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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.
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.
Conditions
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Ergocalciferol
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Healthy Group
40 Healthy individuals will receive a single dose of ergocalciferol (200,000 units)
Group Type
EXPERIMENTAL
Ergocalciferol
Intervention Type
DRUG
Investigational drug will be administered to eligible participants in a single dose of 200,000 USP units vitamin D
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)
Group Type
EXPERIMENTAL
Ergocalciferol
Intervention Type
DRUG
Investigational drug will be administered to eligible participants in a single dose of 200,000 USP units vitamin D
Interventions
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Ergocalciferol
Investigational drug will be administered to eligible participants in a single dose of 200,000 USP units vitamin D
Intervention Type
DRUG
Other Intervention Names
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Drisdol
Calciferol
Calcidol
Vitamin D2
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Anthony J. Bleyer, MD, M.S
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB00054784
Identifier Type: -
Identifier Source: org_study_id