NCT01871389

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

1.5 years

First QC Date

June 4, 2013

Last Update Submit

May 7, 2014

Conditions

Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Serum 25(OH)D3

    Change at 3 and 6 mos

Study Arms (2)

cholecalciferol

usual treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

bariatric surgery

You may qualify if:

  • morbidly obese meeting criteria for gastric bypass over age 18

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Bariatric Surgery Center

Lubbock, Texas, 79410, United States

Location

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 6, 2013

Study Start

February 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

US(1)