Improving the Understanding of the Response to Vitamin D Supplementation

NCT01465178 | Completed Phase 3 Results

• 1 other identifier: 2011-0601
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

It is the investigators hypothesis that the current method of evaluating vitamin D status, measuring circulating 25-hydroxy vitamin D is not providing the full metabolic picture, and is therefore inadequate. The investigators liken this concept to the evolution of cholesterol where initially, total cholesterol was the only measurement, and have since determined the importance of HDL, LDL and triglycerides in evaluating patient status. Similarly, the investigators feel measurement of other vitamin D components such as sulfated vitamin D, circulating vitamin D3 and 3-epi 25-hydroxy vitamin D will offer more comprehensive information about a patient's vitamin D status. It is our overarching hypothesis that a "vitamin D assay panel," will enhance understanding of vitamin D status. It is our expectation that the enhanced understanding based on improved measurement capability will ultimately translate to improved definition of vitamin D status and need for supplementation on an individual level.

Conditions

Vitamin D Deficiency

Keywords

hypovitaminosis D; vitamin D insufficiency; low vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in Serum 25-hydroxy Vitamin D3

  Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;

  Baseline, 1 and 4 months post supplementation

Secondary Outcomes (1)

• Change in Parameters of the Vitamin D Assay Panel

  Baseline, 1 and 4 months post supplementation

Study Arms (2)

2000 IU vitamin D3

ACTIVE COMPARATOR

Cholecalciferol 2,000 IU capsules

Dietary Supplement: cholecalciferol

Placebo

PLACEBO COMPARATOR

Non-matching placebo, gelatin filled capsules

Dietary Supplement: Placebo

Interventions

cholecalciferol DIETARY_SUPPLEMENT

2000 IU cholecalciferol gelcaps by mouth daily

2000 IU vitamin D3

Placebo DIETARY_SUPPLEMENT

matching placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, community-dwelling ambulatory postmenopausal White, non-Hispanic women
• Able and willing to sign informed consent
• Baseline serum 25(OH)D concentration of 10-29 ng/mL
• Willing to not alter the amount of their baseline vitamin D supplementation during the course of this study
• Willing to use sunscreen (SPF ≥15) when sun exposure of \> 15 minutes is expected

You may not qualify if:

• Presence of any measurable circulating 25(OH)D2 on screening measurement
• Current hypercalcemia (serum calcium \> 10.5 mg/dl) or untreated primary hyperparathyroidism
• History of nephrolithiasis
• Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis
• History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma
• Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault approach) of ≤ 35 ml/minute
• Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study
• Known metabolic bone disease, e.g., Paget's disease, osteomalacia
• Treatment with any drug known to interfere with vitamin D metabolism, e.g., phenytoin, phenobarbital
• Treatment with high dose vitamin D (≥ 50,000 IU weekly) or any active metabolites of vitamin D, e.g., calcitriol, within six months of screening
• Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer
• Planned trips/vacations likely to be associated with substantial amounts of sun exposure during the course of the study

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Neil Binkley
• Organization: University of Wisconsin

nbinkley@wisc.edu

608-265-6410

Study Officials

• Neil Binkley, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 4, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 25, 2016
• Results First Posted: November 25, 2016

Record last verified: 2016-10

Locations

US (1)