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
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
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
NCT ID
NCT03099759
First Posted
March 23, 2017
Last Updated
June 20, 2017
Sponsor
The Cleveland Clinic
Collaborators
Brentwood Foundation
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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