Obesity Clinical Trial
Official title:
Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery
Verified date | June 2020 |
Source | Region Östergötland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 260 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Informed consent - Patients subjected to bariatric surgery at Vrinnevi Hospital, Norrköping, Sweden Exclusion Criteria: - Unable to read and understand Swedish |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Surgery, Vrinnevi Hospital | Norrkoping |
Lead Sponsor | Collaborator |
---|---|
Region Östergötland |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to vitamin and mineral supplementation | Implementation (Continuous multiple-interval measures of medication availability/gaps, CMA), | 5 years | |
Primary | Time to initiation | Initiation (time to initiation) | 1 year | |
Primary | Time to discontinuation | Discontinuation (Time to discontinuation) | 5 years | |
Secondary | 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 | |
Secondary | Hemoglobin (Hb) | g/L | 5 years | |
Secondary | Iron status | µmol/L | 5 years | |
Secondary | s-folate | nmol/L | 5 years | |
Secondary | p-calcium | mmol/L | 5 years | |
Secondary | s-albumin | g/L | 5 years | |
Secondary | s-cobolamin | pmol/L | 5 years |
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