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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04412421
Other study ID # Vitamin study 01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 3, 2017
Est. completion date July 1, 2023

Study information

Verified date June 2020
Source Region Östergötland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Gastric Bypass, Sleeve Gastrectomy
Lifelong vitamin and Mineral supplementation

Locations

Country Name City State
Sweden Department of Surgery, Vrinnevi Hospital Norrkoping

Sponsors (1)

Lead Sponsor Collaborator
Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

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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