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Treatment of Vitamin D Insufficiency

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00933244
First received: July 2, 2009
Last updated: October 6, 2015
Last verified: October 2015
Results First Received: June 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Vitamin D Deficiency
Interventions: Dietary Supplement: High Dose Vitamin D3
Dietary Supplement: Low Dose Vitamin D3
Dietary Supplement: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Dose Vitamin D

Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.

Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.

High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.

Placebo: White gel-cap placebo pills to take orally, daily for 355 days.

Low Dose Vitamin D

Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.

Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.

Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days

Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.

Placebo

Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.

Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.

Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.

Placebo: White gel-cap placebo pills to take orally, daily for 355 days.


Participant Flow:   Overall Study
    High Dose Vitamin D   Low Dose Vitamin D   Placebo
STARTED   79   75   76 
COMPLETED   74   74   73 
NOT COMPLETED   5   1   3 
Withdrawal by Subject                5                1                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized subjects' baseline data is reported herein

Reporting Groups
  Description
High Dose Vitamin D

Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.

Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.

High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.

Placebo: White gel-cap placebo pills to take orally, daily for 355 days.

Low Dose Vitamin D

Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.

Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.

Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days

Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.

Placebo

Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.

Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.

Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.

Placebo: White gel-cap placebo pills to take orally, daily for 355 days.

Total Total of all reporting groups

Baseline Measures
   High Dose Vitamin D   Low Dose Vitamin D   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 79   75   76   230 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (5)   60  (6)   61  (6)   61  (6) 
Gender 
[Units: Participants]
       
Female   79   75   76   230 
Male   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   2   0   0   2 
Asian   3   1   1   5 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   1   7   6   14 
White   73   67   69   209 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   79   75   76   230 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intestinal Calcium Absorption   [ Time Frame: One Year ]

2.  Secondary:   Bone Mineral Density   [ Time Frame: 1 Year ]

3.  Other Pre-specified:   Bone Turnover   [ Time Frame: 0, 30, 60, 120, 365 days ]

4.  Other Pre-specified:   Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test   [ Time Frame: 1 Year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Karen E Hansen
Organization: University of Wisconsin - School of Medicine & Public Health
phone: 608-265-8162
e-mail: keh@medicine.wisc.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00933244     History of Changes
Other Study ID Numbers: H-2009-0055
R01AG028739 ( US NIH Grant/Contract Award Number )
supplement ( Other Identifier: Office of Dietary Supplements )
Study First Received: July 2, 2009
Results First Received: June 16, 2015
Last Updated: October 6, 2015
Health Authority: United States: Institutional Review Board