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Supplementation After Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412421
Recruitment Status : Active, not recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Ellen Andersson, Region Östergötland

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.

Condition or disease Intervention/treatment
Bariatric Surgery Micronutrient Deficiencies Obesity Procedure: Gastric Bypass, Sleeve Gastrectomy

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.

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Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Gastric Bypass, Sleeve Gastrectomy
    Lifelong vitamin and Mineral supplementation
    Other Name: Vitamin and Mineral supplementation


Primary Outcome Measures :
  1. Adherence to vitamin and mineral supplementation [ Time Frame: 5 years ]
    Implementation (Continuous multiple-interval measures of medication availability/gaps, CMA),

  2. Time to initiation [ Time Frame: 1 year ]
    Initiation (time to initiation)

  3. Time to discontinuation [ Time Frame: 5 years ]
    Discontinuation (Time to discontinuation)


Secondary Outcome Measures :
  1. Self reported Adherence to vitamin-and mineral supplementation [ Time Frame: 5 years ]
    Medication Adherence Report Scale (MARS-5) score 1-25, higher scores mean a better outcome

  2. Hemoglobin (Hb) [ Time Frame: 5 years ]
    g/L

  3. Iron status [ Time Frame: 5 years ]
    µmol/L

  4. s-folate [ Time Frame: 5 years ]
    nmol/L

  5. p-calcium [ Time Frame: 5 years ]
    mmol/L

  6. s-albumin [ Time Frame: 5 years ]
    g/L

  7. s-cobolamin [ Time Frame: 5 years ]
    pmol/L



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients subjected to bariatric surgery at Vrinnevi Hospital
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to read and understand Swedish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412421


Locations
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Sweden
Department of Surgery, Vrinnevi Hospital
Norrkoping, Sweden, 60379
Sponsors and Collaborators
Region Östergötland
Investigators
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Principal Investigator: Ellen Andersson Region Östergötland
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Responsible Party: Ellen Andersson, MD, PhD, Consultant Upper GI Surgeon, Region Östergötland
ClinicalTrials.gov Identifier: NCT04412421    
Other Study ID Numbers: Vitamin study 01
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ellen Andersson, Region Östergötland:
Bariatric Surgery (Gastric Bypass, Gastric Sleeve)
Micronutrient Deficiencies
Adherence, Medication
Additional relevant MeSH terms:
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Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs