Supplementation After Bariatric Surgery

Study Overview
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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.

Official Title
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Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery

Conditions
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Micronutrient Deficiencies, Bariatric Surgery, Obesity

Intervention / Treatment
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* Procedure: Gastric Bypass, Sleeve Gastrectomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Gastric Bypass, Sleeve Gastrectomy|Lifelong vitamin and Mineral supplementation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to vitamin and mineral supplementation | Implementation (Continuous multiple-interval measures of medication availability/gaps, CMA), | 5 years | 
| Time to initiation | Initiation (time to initiation) | 1 year | 
| Time to discontinuation | Discontinuation (Time to discontinuation) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported Adherence to vitamin-and mineral supplementation | Medication Adherence Report Scale (MARS-5) score 1-25, higher scores mean a better outcome | 5 years | 
| Hemoglobin (Hb) | g/L | 5 years | 
| Iron status | µmol/L | 5 years | 
| s-folate | nmol/L | 5 years | 
| p-calcium | mmol/L | 5 years | 
| s-albumin | g/L | 5 years | 
| s-cobolamin | pmol/L | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Surgery (Gastric Bypass, Gastric Sleeve), Micronutrient Deficiencies, Adherence, Medication