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Vitamin D Levels in Children With IBD

This study has been terminated.
(Maintenance phase outcome unattenable)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621257
First Posted: February 22, 2008
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Crohn's and Colitis Foundation
NASPGHAN Foundation
Information provided by (Responsible Party):
Helen Pappa, Boston Children's Hospital
Results First Submitted: December 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Interventions: Dietary Supplement: ergocalciferol
Dietary Supplement: Cholecalciferol

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment A

2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)

ergocalciferol: 8000 units/ml

Treatment B

2,000 IU/day of vitamin D3 orally for 6 weeks

Cholecalciferol: 400 units per drop

Treatment C

50,000 IU of vitamin D2 once a week orally for 6 weeks

ergocalciferol: 8000 units/ml

Maintenance A

400 IU/day of vitamin D2 orally over 2 years (control arm)

ergocalciferol: 8000 units/ml

Maintenance B

2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years

ergocalciferol: 8000 units/ml


Participant Flow:   Overall Study
    Treatment A   Treatment B   Treatment C   Maintenance A   Maintenance B
STARTED   24   24   23   32   31 
COMPLETED   20   21   20   26   22 
NOT COMPLETED   4   3   3   6   9 
Lost to Follow-up                4                0                2                4                7 
Adverse Event                0                1                1                0                0 
Physician Decision                0                2                0                1                1 
Withdrawal by Subject                0                0                0                1                1 



  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
Treatment A

2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)

ergocalciferol: 8000 units/ml

Treatment B

2,000 IU/day of vitamin D3 orally for 6 weeks

Cholecalciferol: 400 units per drop

Treatment C

50,000 IU of vitamin D2 once a week orally for 6 weeks

ergocalciferol: 8000 units/ml

Maintenance A

400 IU/day of vitamin D2 orally over 2 years (control arm)

ergocalciferol: 8000 units/ml

Maintenance B

2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years

ergocalciferol: 8000 units/ml

Total Total of all reporting groups

Baseline Measures
   Treatment A   Treatment B   Treatment C   Maintenance A   Maintenance B   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   23   32   31   134 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.9  (3)   14.7  (3.5)   16.3  (3.2)   15.1  (3.1)   14.5  (3.1)   15.2  (3.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      10  41.7%      14  58.3%      9  39.1%      19  59.4%      17  54.8%      69  51.5% 
Male      14  58.3%      10  41.7%      14  60.9%      13  40.6%      14  45.2%      65  48.5% 


  Outcome Measures
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1.  Primary:   Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease   [ Time Frame: 6 weeks ]

2.  Secondary:   Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease   [ Time Frame: 12 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: Helen Pappa, MD, MPH, Principal Investigator
Organization: children's Hospital Boston
phone: 617-355-6058
e-mail: helen.pappa@childrens.harvard.edu


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

Responsible Party: Helen Pappa, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00621257     History of Changes
Other Study ID Numbers: 1K23DK076979-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 11, 2008
First Posted: February 22, 2008
Results First Submitted: December 27, 2016
Results First Posted: February 17, 2017
Last Update Posted: March 22, 2017