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Vitamin D Raising and Maintaining Blood Serum 25(OH)D3 Levels (VitD)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D Dosing Regimens, Blood Serum 25(OH)D3 Levels

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Low Vitamin D level

Exclusion Criteria:

  • Normal Vitamin D level, already taking Vitamin D, any form of steroids, weight-loss drugs, anti-tuberculosis drugs, high blood pressure drugs, high cholesterol drugs, endocrine disease, being treated for any form of cancer.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Vitamin Dose Group 100,000 Units

    Vitamin Dose Group 100,000 Units D2

    Vitamin Dose Group 50,000/2,000 D2/D3

    Arm Description

    100,000 units Vitamin D2 one time only.

    100,000 units vitamin D2 weekly for three months.

    50,000 units Vitamin D2 for 10 days followed by 2,000 units Vitamin D3 daily the remainder of the three month study period.

    Outcomes

    Primary Outcome Measures

    Vitamin D
    Effectiveness of various Vitamin D protocols on raising and maintaining blood serum 25(OH)D3 levels over a three month period from baseline to 3 months with participants blood draws at initial, week 2, week 6 and week 12 time frame.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2017
    Last Updated
    June 20, 2017
    Sponsor
    The Cleveland Clinic
    Collaborators
    Brentwood Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03099759
    Brief Title
    Vitamin D Raising and Maintaining Blood Serum 25(OH)D3 Levels
    Acronym
    VitD
    Official Title
    Effectiveness of Various Vitamin D Protocols on Raising and Maintaining Blood Serum 25(OH)D3 Levels Over a Three Month Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 27, 2016 (Actual)
    Primary Completion Date
    May 31, 2017 (Actual)
    Study Completion Date
    May 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Cleveland Clinic
    Collaborators
    Brentwood Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different dosing groups and how their levels change over a 3 month period of time.
    Detailed Description
    Vitamin D has shown multiple health benefits specifically in regards to bone healing. To the investigators knowledge there are currently no protocols for Vitamin D supplementation in the Orthopedic community for patients recovering from fractures. The investigators study will monitor 3 different groups of volunteers taking various Vitamin D regimens and how participants blood serum 25(OH)D3 levels are effected throughout a 3 month period. The 3 groups will include: 1) 100,000 units D2 once on day one, 2) 100,000 units D2 taken once a week x 12 weeks, 3) 50,000 units D2 x 10 days, then 2000 units D3 taken daily for the remainder of the study period. There will be 15-20 volunteers randomly assigned to each of the 3 groups. The investigators will have each volunteer from the 3 groups have blood drawn a total of 4 times throughout the course of this study: prior to the study, week 2, week 6, and week 12. From these results the investigators will determine which protocol most effectively raises and maintains vitamin D levels in the volunteers through this 3 month period. The investigators will also use this data to determine which protocol is not only most cost efficient but also easiest to follow by individuals. The investigators are hoping that this study may help finally develop a universal orthopedic protocol for vitamin D supplementation in patients recovering from fractures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency
    Keywords
    Vitamin D Dosing Regimens, Blood Serum 25(OH)D3 Levels

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin Dose Group 100,000 Units
    Arm Type
    Active Comparator
    Arm Description
    100,000 units Vitamin D2 one time only.
    Arm Title
    Vitamin Dose Group 100,000 Units D2
    Arm Type
    Active Comparator
    Arm Description
    100,000 units vitamin D2 weekly for three months.
    Arm Title
    Vitamin Dose Group 50,000/2,000 D2/D3
    Arm Type
    Active Comparator
    Arm Description
    50,000 units Vitamin D2 for 10 days followed by 2,000 units Vitamin D3 daily the remainder of the three month study period.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D
    Other Intervention Name(s)
    Ergocalciferol, cholecalciferol
    Intervention Description
    Vitamin D2/D3
    Primary Outcome Measure Information:
    Title
    Vitamin D
    Description
    Effectiveness of various Vitamin D protocols on raising and maintaining blood serum 25(OH)D3 levels over a three month period from baseline to 3 months with participants blood draws at initial, week 2, week 6 and week 12 time frame.
    Time Frame
    Three Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Low Vitamin D level Exclusion Criteria: Normal Vitamin D level, already taking Vitamin D, any form of steroids, weight-loss drugs, anti-tuberculosis drugs, high blood pressure drugs, high cholesterol drugs, endocrine disease, being treated for any form of cancer.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Damien Billow, MD
    Organizational Affiliation
    The Cleveland Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Vitamin D Raising and Maintaining Blood Serum 25(OH)D3 Levels

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