Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

This study has been completed.
Sponsor:
Collaborator:
Bio-Tech Pharmacal, Inc.
Information provided by (Responsible Party):
Leigh Eck, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00903344
First received: May 14, 2009
Last updated: August 4, 2014
Last verified: August 2014
Results First Received: May 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Osteoporosis
Interventions: Drug: Vitamin D3
Dietary Supplement: Multivitamin

  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
Vitamin D - Experimental

4000IU Vitamin D3 in tablet taken daily with multivitamin

Vitamin D3: 4000IU vitamin D3 tablet taken daily

Multivitamin - Active Comparator

Multivitamin with 400IU vitamin D tablet

Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily


Participant Flow:   Overall Study
    Vitamin D - Experimental     Multivitamin - Active Comparator  
STARTED     12     10  
3 Month Visit     10     10  
6 Month Visit     9     10  
COMPLETED     7     7  
NOT COMPLETED     5     3  
Pregnancy                 2                 3  
Lost to Follow-up                 3                 0  



  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.
No text entered.

Reporting Groups
  Description
Vitamin D - Experimental

4000IU Vitamin D3 in tablet taken daily with multivitamin

Vitamin D3: 4000IU vitamin D3 tablet taken daily

Multivitamin - Active Comparator

Multivitamin with 400IU vitamin D tablet

Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily

Total Total of all reporting groups

Baseline Measures
    Vitamin D - Experimental     Multivitamin - Active Comparator     Total  
Number of Participants  
[units: participants]
  12     10     22  
Age  
[units: years]
Mean ± Standard Deviation
  29  ± 6     32  ± 3     30  ± 4.64  
Gender  
[units: participants]
     
Female     12     10     22  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     12     10     22  



  Outcome Measures
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1.  Primary:   Change in Bone Mineral Density (BMD) in HIP at 6 Months   [ Time Frame: Change from Baseline to 6 months ]

2.  Secondary:   Change in 25-hyroxyvitamin D Levels at 3 Months   [ Time Frame: Change from Baseline to 3 Months ]

3.  Secondary:   Change in 25-hyroxyvitamin D Levels at 6 Months   [ Time Frame: Change from Baseline to 6 Months ]

4.  Secondary:   Change in Bone Mineral Density (BMD) at HIP at 3 Months   [ Time Frame: Change from Baseline to 3 months ]

5.  Secondary:   Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months   [ Time Frame: Change from Baseline to 3 Months ]

6.  Secondary:   Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months   [ Time Frame: Change from Baseline to 6 Months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Leigh Eck
Organization: University of Kansas Medical Center
phone: 913-588-6022
e-mail: leck2@kumc.edu


No publications provided


Responsible Party: Leigh Eck, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00903344     History of Changes
Other Study ID Numbers: 11711
Study First Received: May 14, 2009
Results First Received: May 22, 2014
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration