Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects

Bariatric Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871389
• Other study ID #: Vitamin D3
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: May 7, 2014
• Start date: February 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Vitamin D deficiency is common after bariatric surgery. This study is designed to determine if a high dose monthly supplement of vitamin D 3 will be effective in helping improve vitamin D status after surgery such as gastric bypass. Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• morbidly obese meeting criteria for gastric bypass over age 18

Exclusion Criteria:

• taking medications that affect vitamin D status, elevated serum hydroxy vit D or calcium

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bariatric Surgery

Locations

Country	Name	City	State
United States	Advanced Bariatric Surgery Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25(OH)D3		Change at 3 and 6 mos	No