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Safety and Bioefficacy of Vitamin D2 and Vitamin D3

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cholecalciferol
ergocalciferol
Placebo
Sponsored by
Ulrike Lehmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vitamin D Deficiency focused on measuring randomized controlled trial, vitamin D, bioavailability

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years
  • healthy

Exclusion Criteria:

  • supplementation of vitamin d and calcium
  • hypercalcemia
  • hypercalciuria
  • chronical illness (diabetes, kidney diseases, cardiovascular diseases)
  • serum-creatinine above 115 mmol/l
  • pregnancy or breastfeeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    cholecalciferol

    Ergocalciferol

    Placebo

    Arm Description

    Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks

    Ergocalciferol 2000 IU per day for 8 weeks

    Placebo for 8 weeks

    Outcomes

    Primary Outcome Measures

    change of 25-hydroxvitamin D

    Secondary Outcome Measures

    Full Information

    First Posted
    October 24, 2011
    Last Updated
    October 7, 2012
    Sponsor
    Ulrike Lehmann
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01503216
    Brief Title
    Safety and Bioefficacy of Vitamin D2 and Vitamin D3
    Official Title
    Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ulrike Lehmann

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.
    Detailed Description
    Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells. Groups/Cohorts Assigned Interventions Placebo group Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule) Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency
    Keywords
    randomized controlled trial, vitamin D, bioavailability

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cholecalciferol
    Arm Type
    Experimental
    Arm Description
    Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks
    Arm Title
    Ergocalciferol
    Arm Type
    Experimental
    Arm Description
    Ergocalciferol 2000 IU per day for 8 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for 8 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    cholecalciferol
    Other Intervention Name(s)
    Cholecalciferol, vitamin D3
    Intervention Description
    cholecalciferol, 2000 IU per day, 8 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    ergocalciferol
    Intervention Description
    vitamin d2, 2000 IU per day for 8 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    change of 25-hydroxvitamin D
    Time Frame
    after 4 and 8 weeks of supplementation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years healthy Exclusion Criteria: supplementation of vitamin d and calcium hypercalcemia hypercalciuria chronical illness (diabetes, kidney diseases, cardiovascular diseases) serum-creatinine above 115 mmol/l pregnancy or breastfeeding women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jutta Dierkes, Prof. Dr.
    Organizational Affiliation
    Institut für Agrar- und Ernährungswissenschaften
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24001747
    Citation
    Lehmann U, Hirche F, Stangl GI, Hinz K, Westphal S, Dierkes J. Bioavailability of vitamin D(2) and D(3) in healthy volunteers, a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Nov;98(11):4339-45. doi: 10.1210/jc.2012-4287. Epub 2013 Sep 3.
    Results Reference
    derived

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    Safety and Bioefficacy of Vitamin D2 and Vitamin D3

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