Supplementation After Bariatric Surgery | NCT04412421

Studies
Supplementation After Bariatric Surgery

NCT04412421

Sponsor

Region Östergötland

Status

Unknown status

Last Update Posted

Jun 2, 2020Actual

Enrollment

260Actual

Phase

Not provided

Conditions

Bariatric Surgery
Micronutrient Deficiencies
Obesity

Interventions

Gastric Bypass, Sleeve Gastrectomy

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 3, 2017Actual

Primary Completion Date

Jul 1, 2020Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Feb 7, 2020

First Submission Date that Met QC Criteria

Jun 1, 2020

First Posted Date

Jun 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2020

Last Update Posted Date

Jun 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ellen Andersson, MD, PhD, Consultant Upper GI Surgeon, Region ÖstergötlandPrincipal Investigator

Lead Sponsor

Region ÖstergötlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric Bypass, Sleeve Gastrectomy	Procedure	Lifelong vitamin and Mineral supplementation		Vitamin and Mineral supplementation

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unable to read and understand Swedish

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients subjected to bariatric surgery at Vrinnevi Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen Andersson	Region Östergötland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Vrinnevi Hospital		Norrköping		60379	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D055118	Medication Adherence

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015390	Gastric Bypass
D014815	Vitamins

Ancestor Terms

ID	Term
D050110	Bariatric Surgery
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided