Supplementation After Bariatric Surgery

Obesity Clinical Trial

Official title:

Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04412421
• Other study ID #: Vitamin study 01
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Micronutrient Deficiencies
• Obesity

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