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Improving the Understanding of the Response to Vitamin D Supplementation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01465178
First received: October 27, 2011
Last updated: October 24, 2014
Last verified: October 2014

October 27, 2011
October 24, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
Change in serum 25-hydroxy vitamin D3 [ Time Frame: Baseline, 1 and 4 months post supplementation ] [ Designated as safety issue: No ]
Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;
Same as current
Complete list of historical versions of study NCT01465178 on ClinicalTrials.gov Archive Site
Change in parameters of the vitamin D assay panel [ Time Frame: Baseline, 1 and 2 months post supplementation ] [ Designated as safety issue: No ]
Secondary outcomes are change in cholecalciferol, 3 epi-25(OH)D3 and sulfated 25(OH)D3.
Same as current
Not Provided
Not Provided
 
Improving the Understanding of the Response to Vitamin D Supplementation
Improving the Understanding of the Response to Vitamin D Supplementation

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.

This hypothesis is supported by several observations. First, recent work finds previously unappreciated vitamin D metabolites, notably 3 epi-25(OH)D348 and sulfated 25(OH)D3, in virtually all human sera and circulating in amounts that vary widely between individuals. These compounds may be measured by current "25(OH)D" assays,46, 63 and thereby confound accuracy of such measurements. Secondly, substantial but inadequately understood variability of 25(OH)D response to supplementation and UV exposure exists.15, 42-44 It is likely that currently unappreciated genetic and/or physiologic factors, e.g., differences in absorption or degradation, underpin these observations. Our panel will allow definition of these differences. Finally, the inadequacy of our current approach to classify vitamin D status (singular 25(OH)D measurement) is exemplified by the great between-individual variability in the PTH/25(OH)D relationship as noted above.8, 64 Thus, the investigators believe that exploration of a "vitamin D assay panel," consisting of measurements that reflect input (cholecalciferol and ergocalciferol) and confounders to the 25(OH)D assay [3 epi-25(OH)D and sulfated 25(OH)D] is essential to accurately define optimal vitamin D status and to determine the ideal approach for vitamin D repletion.

To begin testing this hypothesis, the Specific Aims of this research are to document the vitamin D profile response defined as change in serum concentration of:

  1. 25(OH)D
  2. cholecalciferol
  3. 3 epi-25(OH)D
  4. Sulfated 25(OH)D following four months of supplementation with 2,200 IU of daily vitamin D3 in postmenopausal women. Our primary outcome variable is the effect of supplementation on serum 25(OH)D3; secondary outcomes are change in cholecalciferol, 3 epi-25(OH)D3 and sulfated 25(OH)D3.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Vitamin D Deficiency
  • Dietary Supplement: cholecalciferol
    2000 IU cholecalciferol gelcaps by mouth daily
  • Dietary Supplement: Placebo
    matching placebo
  • Active Comparator: 2000 IU vitamin D3
    Intervention: Dietary Supplement: cholecalciferol
  • Placebo Comparator: Matching Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
62
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy, community-dwelling ambulatory postmenopausal White, non-Hispanic women
  • Able and willing to sign informed consent
  • Baseline serum 25(OH)D concentration of 12-20 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

Exclusion Criteria:

  • 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
Female
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01465178
2011-0601
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Merck Sharp & Dohme Corp.
Not Provided
University of Wisconsin, Madison
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP