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

  • Sweden
      • Norrkoping, Sweden, 60379
        • Department of Surgery, Vrinnevi Hospital

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

Region Östergötland

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.

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