NCT04412421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 2, 2020

Status Verified

June 1, 2020

Enrollment Period

3.2 years

First QC Date

February 7, 2020

Last Update Submit

June 1, 2020

Conditions

Bariatric SurgeryMicronutrient DeficienciesObesity

Keywords

Bariatric Surgery (Gastric Bypass, Gastric Sleeve)Micronutrient DeficienciesAdherence, Medication

Outcome Measures

Primary Outcomes (3)

  • 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 (7)

  • Self reported Adherence to vitamin-and mineral supplementation

    5 years

  • Hemoglobin (Hb)

    5 years

  • Iron status

    5 years

  • s-folate

    5 years

  • p-calcium

    5 years

  • +2 more secondary outcomes

Interventions

Gastric Bypass, Sleeve GastrectomyPROCEDURE

Lifelong vitamin and Mineral supplementation

Also known as: Vitamin and Mineral supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients subjected to bariatric surgery at Vrinnevi Hospital

You may qualify if:

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

You may not qualify if:

  • Unable to read and understand Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Vrinnevi Hospital

Norrköping, 60379, Sweden

Location

MeSH Terms

Conditions

ObesityMedication Adherence

Interventions

Gastric BypassVitamins

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical ProceduresMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ellen Andersson

    Region Östergötland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Consultant Upper GI Surgeon

Study Record Dates

First Submitted

February 7, 2020

First Posted

June 2, 2020

Study Start

May 3, 2017

Primary Completion

July 1, 2020

Study Completion

July 1, 2023

Last Updated

June 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)