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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099759
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
Brentwood Foundation
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effectiveness of Various Vitamin D Protocols on Raising and Maintaining Blood Serum 25(OH)D3 Levels Over a Three Month Period
Actual Study Start Date : June 27, 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin Dose Group 100,000 Units
100,000 units Vitamin D2 one time only.
Dietary Supplement: Vitamin D
Vitamin D2/D3
Other Name: Ergocalciferol, cholecalciferol

Active Comparator: Vitamin Dose Group 100,000 Units D2
100,000 units vitamin D2 weekly for three months.
Dietary Supplement: Vitamin D
Vitamin D2/D3
Other Name: Ergocalciferol, cholecalciferol

Active Comparator: Vitamin Dose Group 50,000/2,000 D2/D3
50,000 units Vitamin D2 for 10 days followed by 2,000 units Vitamin D3 daily the remainder of the three month study period.
Dietary Supplement: Vitamin D
Vitamin D2/D3
Other Name: Ergocalciferol, cholecalciferol




Primary Outcome Measures :
  1. Vitamin D [ Time Frame: Three Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03099759


Sponsors and Collaborators
The Cleveland Clinic
Brentwood Foundation
Investigators
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Principal Investigator: Damien Billow, MD The Cleveland Clinic
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03099759    
Other Study ID Numbers: IRB 16-028
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
Vitamin D Dosing Regimens
Blood Serum 25(OH)D3 Levels
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents