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Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients

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ClinicalTrials.gov Identifier: NCT01385098
Recruitment Status : Completed
First Posted : June 29, 2011
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
Texas Woman's University
The Methodist Hospital System
Information provided by (Responsible Party):
Vadim Sherman, MD, The Methodist Hospital System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Obesity
Vitamin D Deficiency
Intervention: Dietary Supplement: Vitamin D3 and Calcium

  Participant Flow

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
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Reporting Groups
  Description
Vitamin D3 and Calcium

Dietary supplement of vitamin D3 and calcium

Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day


Participant Flow:   Overall Study
    Vitamin D3 and Calcium
STARTED   37 
COMPLETED   23 [1] 
NOT COMPLETED   14 
Adverse Event                10 
Lost to Follow-up                4 
[1] 14 subjects did not complete. 4 subjects loss to follow-up & 10 subjects could not tolerate suppl.



  Baseline Characteristics

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.
Number of completers

Reporting Groups
  Description
Vitamin D3 and Calcium

Dietary supplement of vitamin D3 and calcium

Vitamin D3 and Calcium: 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day


Baseline Measures
   Vitamin D3 and Calcium 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Years]
Mean (Standard Deviation)
 41  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3  13.0% 
Not Hispanic or Latino      20  87.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      9  39.1% 
White      14  60.9% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   23 
BMI, kg/m^2 
[Units: Kg/m^2]
Mean (Standard Deviation)
 46.3  (8.1) 
Body weight, lb 
[Units: Lb]
Mean (Standard Deviation)
 278  (52) 
Excess body weight, lb 
[Units: Lb]
Mean (Standard Deviation)
 128  (47) 
Surgery type 
[Units: Participants]
Count of Participants
 
Sleeve Gastrectomy      11  47.8% 
Roux-Y Gastric Bypass      12  52.2% 


  Outcome Measures

1.  Primary:   Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation   [ Time Frame: baseline and 12 weeks ]

2.  Secondary:   Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Sherman Vadim
Organization: Houston Methodist Hosptial
phone: 713-441-5514
e-mail: vsherman@tmhs.org


Publications of Results:
Other Publications:

Responsible Party: Vadim Sherman, MD, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01385098     History of Changes
Other Study ID Numbers: Pro00005625
0311-0034 ( Other Identifier: HMRI IRB )
First Submitted: June 28, 2011
First Posted: June 29, 2011
Results First Submitted: October 25, 2016
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018