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

Effectiveness of Various Vitamin D Protocols on Raising and Maintaining Blood Serum 25(OH)D3 Levels Over a Three Month Period

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03099759
Acronym
VitD
Enrollment
49
Registered
2017-04-04
Start date
2016-06-27
Completion date
2017-05-31
Last updated
2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Vitamin D Dosing Regimens, Blood Serum 25(OH)D3 Levels

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

Vitamin D2/D3

Sponsors

Brentwood Foundation
CollaboratorOTHER
The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Vitamin DThree MonthsEffectiveness 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026