Comparative Effectiveness of Vitamin D and Repletion Strategies

NCT01524874 | Completed

• 1 other identifier: H30-B11
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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 screening clinical VitD status frequently, yet become challenged with how to best advise patients regarding repletion of VitD status, i.e. which form of VitD replacement is most effective. It has been recognized that to achieve significant effects - serum concentrations \>30ng/ml (75 nmol/ml) - it is necessary, as well as safe, to recommend substantially higher doses than were previously thought sufficient. These higher doses can be easily achieved orally. This clinical trial aims to compare absorption of three available forms of this fat-soluble vitamin, due to the potential differences in absorption of different preparations. High-quality powdered, chewable and lipid-emulsified VitD are readily available as supplements, yet these have not been systematically compared. This three-arm, randomized clinical trial will compare the difference in serum 25-hydroxycholecalciferol (25-OH)D concentration between the three arms at baseline and after random administration of one of the three VitD preparations for 12-weeks at a dosage of 10,000 IU VitD per day. The investigators hypothesize that the three forms of vitD will result in an equivalent increase in serum 25OHD.

Conditions

Hypovitaminosis D; Insulin Resistance; Diabetes

Keywords

vitamin d; cholecalciferol; nutritional supplements; hypovitaminosis d; klotho; toll like receptor 4

Outcome Measures

Primary Outcomes (1)

• Change in mean serum 25-hydroxycholecalciferol concentration

  To compare the change in serum 25-hydroxycholecalciferol (25-OHD) concentration between three forms of supplemental vitamin D3: a lipid-emulsified form administered in a sesame oil base, a non-emulsified chewable tablet, and a non-emulsified form administered as a capsule, following 12 weeks of supplementation (10,000 IU/day) in D3 insufficient patients (baseline 25-OHD \<33ng/ml (82.5 nmol/ml)) patients.

  Baseline and 12 weeks

Secondary Outcomes (4)

• Proportion of participants reaching 25-hydroxycholecalciferol concentration >=33ng/ml (82.5 nmol/ml) between groups

  12 weeks

• Change in mean Klotho protein concentration

  Baseline and 12 weeks

• Change in Toll-like receptor concentration in monocytes

  Baseline and 12 weeks

• Change in mean cardiometabolic risk factors

  Baseline- 12 weeks

Study Arms (3)

Powder D3 Capsule - 2,000 IU per Cap

ACTIVE COMPARATOR

Vital Nutrients

Dietary Supplement: Vitamin D3

Chewable D3 Tablet - 2,000 IU per Tab

ACTIVE COMPARATOR

Integrative Therapeutics Inc.

Dietary Supplement: Vitamin D3

Liquid D3 Drop - 2,000 IU per Drop

ACTIVE COMPARATOR

Biotics Research

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

10,000 IU per Day for 12 Weeks

Also known as: Calcitriol

Powder D3 Capsule - 2,000 IU per Cap

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bastyr University: lead
• Diabetes Action Research and Education Foundation: collaborator

Study Sites (2)

Lokahi Health Center

Kailua-Kona, Hawaii, 96740, United States

Location

Bastyr University

Kenmore, Washington, 98028, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Insulin Resistance; Diabetes Mellitus; Macular Degeneration, Age-Related, 10

Interventions

Cholecalciferol; Calcitriol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dihydroxycholecalciferols; Hydroxycholecalciferols

Study Officials

• Ryan Bradley, ND, MPH

  Bastyr University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: February 2, 2012
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-01

Locations

US (2)