Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2