Supplementation After Bariatric Surgery

NCT ID: NCT04412421

Last Updated: 2020-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bariatric Surgery Micronutrient Deficiencies Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Gastric Bypass, Sleeve Gastrectomy

Lifelong vitamin and Mineral supplementation

Intervention Type PROCEDURE

Other Intervention Names

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Vitamin and Mineral supplementation

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Patients subjected to bariatric surgery at Vrinnevi Hospital, Norrköping, Sweden

Exclusion Criteria

* Unable to read and understand Swedish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Östergötland

OTHER

Sponsor Role lead

Responsible Party

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Ellen Andersson

MD, PhD, Consultant Upper GI Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen Andersson

Role: PRINCIPAL_INVESTIGATOR

Region Östergötland

Locations

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Department of Surgery, Vrinnevi Hospital

Norrköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Vitamin study 01

Identifier Type: -

Identifier Source: org_study_id

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