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Bariatric SurgeryNCT04412421

Supplementation After Bariatric Surgery

An observational study of Bariatric Surgery and Micronutrient Deficiencies, run by Region Östergötland at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Gastric Bypass, Sleeve Gastrectomy
Type of treatment
Surgery or procedure
How many people
260 participants
Where
1 siteSweden
Study dates
3 May 2017to 1 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients subjected to bariatric surgery at Vrinnevi Hospital

Who may be able to join

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

Who cannot join

  • Unable to read and understand Swedish

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Surgery, Vrinnevi Hospital

    Norrköping, 60379

Other trials in Sweden

About this study

Official title: Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery

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.

Read the 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.

Being tested
Gastric Bypass, Sleeve Gastrectomy
Keywords
Bariatric Surgery (Gastric Bypass, Gastric Sleeve), Micronutrient Deficiencies, Adherence, Medication
Medical subject headings
Obesity, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastric Bypass, Sleeve GastrectomyProcedure or surgery

    Also called Vitamin and Mineral supplementation

    Lifelong vitamin and Mineral supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to vitamin and mineral supplementation

    Implementation (Continuous multiple-interval measures of medication availability/gaps, CMA),

    Measured: 5 years

  2. Time to initiation

    Initiation (time to initiation)

    Measured: 1 year

  3. Time to discontinuation

    Discontinuation (Time to discontinuation)

    Measured: 5 years

Secondary outcomes (7)

  1. Self reported Adherence to vitamin-and mineral supplementation

    Medication Adherence Report Scale (MARS-5) score 1-25, higher scores mean a better outcome

    Measured: 5 years

  2. Hemoglobin (Hb)

    g/L

    Measured: 5 years

  3. Iron status

    µmol/L

    Measured: 5 years

  4. s-folate

    nmol/L

    Measured: 5 years

  5. p-calcium

    mmol/L

    Measured: 5 years

  6. s-albumin

    g/L

    Measured: 5 years

  7. s-cobolamin

    pmol/L

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start3 May 2017
  3. Primary completion1 Jul 2020 (estimated)
  4. Study completion1 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04412421
Sponsor's protocol ID
Vitamin study 01
Status last verified
Jun 2020
First submitted
7 Feb 2020
Last updated
2 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery and Micronutrient Deficiencies, run by Region Östergötland at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to vitamin and mineral supplementation (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04412421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.

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