Vitamin Supplementation After Bariatric Surgery

NCT ID: NCT02686905

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Complications of Bariatric Procedures Avitaminosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Topical vitamin patch

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

Group Type EXPERIMENTAL

PatchMD Vitamin D3/Calcium Patch

Intervention Type DIETARY_SUPPLEMENT

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.

PatchMD Multivitamin Patch

Intervention Type DIETARY_SUPPLEMENT

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.

PatchMD B12 Energy Plus Patch

Intervention Type DIETARY_SUPPLEMENT

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.

Oral vitamins

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

Group Type EXPERIMENTAL

Chewable Multivitamin with Iron

Intervention Type DIETARY_SUPPLEMENT

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.

Chewable Calcium

Intervention Type DIETARY_SUPPLEMENT

Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.

Quick Dissolve B12

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Oral Vitamin Supplementation Transdermal Vitamin Supplementation Transdermal Vitamin Supplementation Transdermal Vitamin Supplementation Oral Vitamin Supplementation Oral Vitamin Supplementation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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California State Polytechnic University, Pomona

OTHER

Sponsor Role lead

Responsible Party

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Rebecca McDorman

Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bonny Burns-Whitmore, DrPH, RD

Role: STUDY_DIRECTOR

Cal Poly Pomona

David M Oliak, MD

Role: STUDY_CHAIR

Oliak Center for Weight Loss

Locations

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Oliak Center for Weight Loss

Brea, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca McDorman, BS

Role: CONTACT

Phone: 9497023182

Email: [email protected]

Facility Contacts

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David Oliak, MD

Role: primary

Other Identifiers

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VitaBari Study

Identifier Type: -

Identifier Source: org_study_id