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Vitamin Supplementation After Bariatric Surgery

Primary Purpose

Complications of Bariatric Procedures, Avitaminosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chewable Multivitamin with Iron
PatchMD Vitamin D3/Calcium Patch
PatchMD Multivitamin Patch
PatchMD B12 Energy Plus Patch
Chewable Calcium
Quick Dissolve B12
Sponsored by
California State Polytechnic University, Pomona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complications of Bariatric Procedures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oliak Center for Weight LossRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Topical vitamin patch

Oral vitamins

Arm Description

Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch

Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Height
Statiometer measurement (cm)
Total Body Water
Total body water (kg) via Tanita scale measurements

Full Information

First Posted
February 4, 2016
Last Updated
September 29, 2016
Sponsor
California State Polytechnic University, Pomona
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1. Study Identification

Unique Protocol Identification Number
NCT02686905
Brief Title
Vitamin Supplementation After Bariatric Surgery
Official Title
Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California State Polytechnic University, Pomona

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications of Bariatric Procedures, Avitaminosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical vitamin patch
Arm Type
Experimental
Arm Description
Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch
Arm Title
Oral vitamins
Arm Type
Experimental
Arm Description
Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12
Intervention Type
Dietary Supplement
Intervention Name(s)
Chewable Multivitamin with Iron
Other Intervention Name(s)
Oral Vitamin Supplementation
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
PatchMD Vitamin D3/Calcium Patch
Other Intervention Name(s)
Transdermal Vitamin Supplementation
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
PatchMD Multivitamin Patch
Other Intervention Name(s)
Transdermal Vitamin Supplementation
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
PatchMD B12 Energy Plus Patch
Other Intervention Name(s)
Transdermal Vitamin Supplementation
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chewable Calcium
Other Intervention Name(s)
Oral Vitamin Supplementation
Intervention Description
Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
Intervention Type
Dietary Supplement
Intervention Name(s)
Quick Dissolve B12
Other Intervention Name(s)
Oral Vitamin Supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fasting Blood Glucose
Description
Glucose (mg/dL)
Time Frame
3 months
Title
Calcium Blood Value
Description
Calcium (mg/dL)
Time Frame
3 months
Title
Iron Blood Value
Description
Ferritin (ng/mL)
Time Frame
3 months
Title
Vitamin B12 Blood Value
Description
B12 (pg/mL)
Time Frame
3 months
Title
Vitamin D Blood Value
Description
Vitamin D, 25-Hydroxy (pg/mL)
Time Frame
3 months
Title
HbA1c Blood Value
Description
Hemoglobin A1c (%)
Time Frame
3 months
Title
Fat Mass Measurement
Description
Fat Mass (kg) via Tanita scale measurements
Time Frame
3 months
Title
Fat Free Mass Measurement
Description
Fat Free Mass (kg) via Tanita scale measurements
Time Frame
3 months
Title
Weight Measurement
Description
Weight (kg) via Tanita scale measurements
Time Frame
3 months
Title
Waist Circumference
Description
Waist circumference (cm)
Time Frame
3 months
Title
Hip Circumference
Description
Hip circumference (cm)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Height
Description
Statiometer measurement (cm)
Time Frame
3 months
Title
Total Body Water
Description
Total body water (kg) via Tanita scale measurements
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca McDorman, BS
Phone
9497023182
Email
rlmcdorman@cpp.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonny Burns-Whitmore, DrPH, RD
Organizational Affiliation
Cal Poly Pomona
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David M Oliak, MD
Organizational Affiliation
Oliak Center for Weight Loss
Official's Role
Study Chair
Facility Information:
Facility Name
Oliak Center for Weight Loss
City
Brea
State/Province
California
ZIP/Postal Code
92821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Oliak, MD
Phone
714-582-2530
Email
info@droliak.com
First Name & Middle Initial & Last Name & Degree
Rebecca McDorman, BS
First Name & Middle Initial & Last Name & Degree
Heather Garcia, BS
First Name & Middle Initial & Last Name & Degree
Corinne Worland, AA
First Name & Middle Initial & Last Name & Degree
Jordyn Shubin

12. IPD Sharing Statement

Plan to Share IPD
No

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Vitamin Supplementation After Bariatric Surgery

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