Supplementation After Bariatric Surgery
June 1, 2020 updated by: Ellen Andersson, Region Östergötland
Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery
The aim of this study is to assess medication adherence to vitamin and mineral supplements after bariatric surgery and identify factors that may influence adherence.
All study participants are prescribed life-long treatment with daily oral vitamin B12 and Calcium/Vitamin-D.
Menstruating women are also prescribed daily oral iron supplementation.
Post-operative adherence rate is retrieved from Pharmacy refill data, collected from the Swedish Prescribed Drug Register, the five first years after bariatric surgery.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to assess medication adherence to vitamin- and mineral supplementation after bariatric surgery, identify factors that may influence adherence, as well as study the development of micronutrient deficinencies detectable by blood sampling.
All study participants are prescribed life-long treatment with daily oral vitamin B12 and Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation.
Post-operative adherence rate is retrieved from pharmacy refill data, collected from The Swedish Prescribed Drug Register, at one, two and five years after bariatric surgery.
Study Type
Observational
Enrollment (Actual)
260
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Norrkoping, Sweden, 60379
- Department of Surgery, Vrinnevi Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients subjected to bariatric surgery at Vrinnevi Hospital
Description
Inclusion Criteria:
- Informed consent
- Patients subjected to bariatric surgery at Vrinnevi Hospital, Norrköping, Sweden
Exclusion Criteria:
- Unable to read and understand Swedish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to vitamin and mineral supplementation
Time Frame: 5 years
|
Implementation (Continuous multiple-interval measures of medication availability/gaps, CMA),
|
5 years
|
|
Time to initiation
Time Frame: 1 year
|
Initiation (time to initiation)
|
1 year
|
|
Time to discontinuation
Time Frame: 5 years
|
Discontinuation (Time to discontinuation)
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self reported Adherence to vitamin-and mineral supplementation
Time Frame: 5 years
|
Medication Adherence Report Scale (MARS-5) score 1-25, higher scores mean a better outcome
|
5 years
|
|
Hemoglobin (Hb)
Time Frame: 5 years
|
g/L
|
5 years
|
|
Iron status
Time Frame: 5 years
|
µmol/L
|
5 years
|
|
s-folate
Time Frame: 5 years
|
nmol/L
|
5 years
|
|
p-calcium
Time Frame: 5 years
|
mmol/L
|
5 years
|
|
s-albumin
Time Frame: 5 years
|
g/L
|
5 years
|
|
s-cobolamin
Time Frame: 5 years
|
pmol/L
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ellen Andersson, Region Östergötland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 3, 2017
Primary Completion (ANTICIPATED)
July 1, 2020
Study Completion (ANTICIPATED)
July 1, 2023
Study Registration Dates
First Submitted
February 7, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (ACTUAL)
June 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 2, 2020
Last Update Submitted That Met QC Criteria
June 1, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vitamin study 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.