Vitamin Supplementation After Bariatric Surgery

September 29, 2016 updated by: Rebecca McDorman, California State Polytechnic University, Pomona

Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery

The objectives in this study are to provide information on the efficacy of transdermal supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric patients, and to determine short-term body composition, HbA1c and fasting plasma glucose outcomes for patients after bariatric surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Brea, California, United States, 92821
        • Recruiting
        • Oliak Center for Weight Loss
        • Contact:
        • Principal Investigator:
          • Rebecca McDorman, BS
        • Sub-Investigator:
          • Heather Garcia, BS
        • Sub-Investigator:
          • Corinne Worland, AA
        • Sub-Investigator:
          • Jordyn Shubin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients currently approved for vertical sleeve or gastric bypass bariatric surgery
  • female patients should not be pregnant or plan to become pregnant

Exclusion Criteria:

  • metal objects in the body
  • current weight greater than 600lbs
  • previous bariatric (revision) surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical vitamin patch
Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch
Dietary supplement: PatchMD Vitamin D3/Calcium Patch
Wear daily: PatchMD Vitamin D3/Calcium patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.
Other Names:
  • Transdermal Vitamin Supplementation
Dietary supplement: PatchMD Multivitamin Patch
Wear daily: PatchMD Multivitamin patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.
Other Names:
  • Transdermal Vitamin Supplementation
Dietary supplement: PatchMD B12 Energy Plus Patch
Wear daily: PatchMD B12 Energy Plus patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.
Other Names:
  • Transdermal Vitamin Supplementation
Experimental: Oral vitamins
Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12
Dietary supplement: Chewable Multivitamin with Iron
Take daily: Chewable Multivitamin with Iron. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
Other Names:
  • Oral Vitamin Supplementation
Dietary supplement: Chewable Calcium
Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
Other Names:
  • Oral Vitamin Supplementation
Dietary supplement: Quick Dissolve B12
Take daily: Quick Dissolve B12. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
Other Names:
  • Oral Vitamin Supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Blood Glucose
Time Frame: 3 months
Glucose (mg/dL)
3 months
Calcium Blood Value
Time Frame: 3 months
Calcium (mg/dL)
3 months
Iron Blood Value
Time Frame: 3 months
Ferritin (ng/mL)
3 months
Vitamin B12 Blood Value
Time Frame: 3 months
B12 (pg/mL)
3 months
Vitamin D Blood Value
Time Frame: 3 months
Vitamin D, 25-Hydroxy (pg/mL)
3 months
HbA1c Blood Value
Time Frame: 3 months
Hemoglobin A1c (%)
3 months
Fat Mass Measurement
Time Frame: 3 months
Fat Mass (kg) via Tanita scale measurements
3 months
Fat Free Mass Measurement
Time Frame: 3 months
Fat Free Mass (kg) via Tanita scale measurements
3 months
Weight Measurement
Time Frame: 3 months
Weight (kg) via Tanita scale measurements
3 months
Waist Circumference
Time Frame: 3 months
Waist circumference (cm)
3 months
Hip Circumference
Time Frame: 3 months
Hip circumference (cm)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height
Time Frame: 3 months
Statiometer measurement (cm)
3 months
Total Body Water
Time Frame: 3 months
Total body water (kg) via Tanita scale measurements
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California State Polytechnic University, Pomona

Investigators

  • Study Director: Bonny Burns-Whitmore, DrPH, RD, Cal Poly Pomona
  • Study Chair: David M Oliak, MD, Oliak Center for Weight Loss

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitaBari Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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