Bariatric SurgeryNCT01871389
Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects
An observational study of Bariatric Surgery, run by Texas Tech University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: bariatric surgery
Who may be able to join
- morbidly obese meeting criteria for gastric bypass over age 18
Who cannot join
- taking medications that affect vitamin D status, elevated serum hydroxy vit D or calcium
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Bariatric Surgery Center
Lubbock, Texas, 79410
About this study
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.
- Conditions
- Bariatric Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cholecalciferol | Not described | |
| usual treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D3
Measured: Change at 3 and 6 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startFeb 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Mallory Boylan, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871389
- Sponsor's protocol ID
- Vitamin D3
- Status last verified
- May 2014
- First submitted
- 4 Jun 2013
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects
- ClinicalTrials.gov ID
- NCT01871389
- Acronym / sponsor ID
- Vitamin D3
- Conditions
- Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cholecalciferol | – | – |
| usual treatment | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- bariatric surgery
Key inclusion criteria (1 listed)
- morbidly obese meeting criteria for gastric bypass over age 18
Key exclusion criteria (1 listed)
- taking medications that affect vitamin D status, elevated serum hydroxy vit D or calcium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum 25(OH)D3
Time frame: Change at 3 and 6 mos
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH)D3 (time frame: Change at 3 and 6 mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.