Status:
COMPLETED
Comparative Effectiveness of Vitamin D and Repletion Strategies
Lead Sponsor:
Bastyr University
Collaborating Sponsors:
Diabetes Action Research and Education Foundation
Conditions:
Hypovitaminosis D
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The importance of vitamin D (VitD) in the prevention and treatment of human health conditions has gained increased attention in recent years. As a result, medical providers of all categories are scree...
Detailed Description
VitD has numerous hormonal effects, including regulation of Ca2+ and Mg2+, as well as effects on numerous genes, including insulin and androgens. Mounting literature demonstrates associations between ...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Between18-65 years of age; there is an age-related decline in the absorption, transport or liver hydroxylation of orally-consumed VitD (Harris, 1999) therefore adults older than 65 will be excluded. This population is also at greater risk of being on medications with potential medication interactions, e.g. anticoagulants.
- Willingness to perform baseline screening tests: serum 25-OHD, CBC, Comprehensive metabolic chemistry panel (electrolytes, hepatic and renal function tests, lipids, HgA1C, insulin and glucose)
- Screening serum 25-OHD \<33ng/ml (82.5 nmol/ml). If \>=33ng/ml (82.5 nmol/ml), subjects will participate in the research study as baseline controls for the nested studies of Klotho and TLR-4.
- Ability to read and speak English
- Willingness to be randomized to one of three active treatments for 3 months
Exclusion
- Subjects who have a serum baseline 25-OHD \>=33ng/ml (82.5 nmol/ml) will be excluded once the VitD sufficient baseline control recruitment goal is met
- Subjects who have historical or current use of extra-dietary VitD, other than what is in a multivitamin, for the previous 3 months.
- LFTs: AST\>60 U/L; ALT\>65 U/L; Alkaline phosphatase \>120 U/L. Total bilirubin\>1.5 mg/dL
- Serum creatinine\>1.4 mg/dL; BUN \>25 mg/dL5. Subjects who are pregnant, or could become pregnant, unless they are using regular birth control (OCPs, condoms, IUD).
- Subjects who have established osteoporosis.
- Subjects who have history or symptoms of a parathyroid disorder.
- Subjects who have difficulty swallowing pills.
- Subjects who are unwilling to use sunscreen.
- Subjects who have had a past adverse reaction to sunscreen.
- Subjects who are taking medications over the previous 3 months that interfere with the metabolism of VitD (anti-convulsants, anti-coagulants, oral corticosteroids, or barbiturates).
- Subjects with any psychological conditions or substance abuse that may make the subject non- adherent, such as history of bipolar disorder, mania, untreated anxiety or other mood disorder, as determined by the site PI.
- Other severe illness or mental incapacity that, in the opinion of the site PI, would render the potential subject incapable of participating in the study.
- Allergy to sesame oil base
- Heart arrhythmia
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01524874
Start Date
August 1 2010
End Date
November 1 2011
Last Update
February 2 2012
Active Locations (2)
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1
Lokahi Health Center
Kailua-Kona, Hawaii, United States, 96740
2
Bastyr University
Kenmore, Washington, United States, 98028