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Vitamin Supplementation After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02686905
Recruitment Status : Unknown
Verified September 2016 by Rebecca McDorman, California State Polytechnic University, Pomona.
Recruitment status was:  Recruiting
First Posted : February 22, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Rebecca McDorman, California State Polytechnic University, Pomona

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.

Condition or disease Intervention/treatment Phase
Complications of Bariatric Procedures Avitaminosis Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Oral Vitamin Supplementation




Primary Outcome Measures :
  1. Fasting Blood Glucose [ Time Frame: 3 months ]
    Glucose (mg/dL)

  2. Calcium Blood Value [ Time Frame: 3 months ]
    Calcium (mg/dL)

  3. Iron Blood Value [ Time Frame: 3 months ]
    Ferritin (ng/mL)

  4. Vitamin B12 Blood Value [ Time Frame: 3 months ]
    B12 (pg/mL)

  5. Vitamin D Blood Value [ Time Frame: 3 months ]
    Vitamin D, 25-Hydroxy (pg/mL)

  6. HbA1c Blood Value [ Time Frame: 3 months ]
    Hemoglobin A1c (%)

  7. Fat Mass Measurement [ Time Frame: 3 months ]
    Fat Mass (kg) via Tanita scale measurements

  8. Fat Free Mass Measurement [ Time Frame: 3 months ]
    Fat Free Mass (kg) via Tanita scale measurements

  9. Weight Measurement [ Time Frame: 3 months ]
    Weight (kg) via Tanita scale measurements

  10. Waist Circumference [ Time Frame: 3 months ]
    Waist circumference (cm)

  11. Hip Circumference [ Time Frame: 3 months ]
    Hip circumference (cm)


Secondary Outcome Measures :
  1. Height [ Time Frame: 3 months ]
    Statiometer measurement (cm)

  2. Total Body Water [ Time Frame: 3 months ]
    Total body water (kg) via Tanita scale measurements



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02686905


Contacts
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Contact: Rebecca McDorman, BS 9497023182 rlmcdorman@cpp.edu

Locations
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United States, California
Oliak Center for Weight Loss Recruiting
Brea, California, United States, 92821
Contact: David Oliak, MD    714-582-2530    info@droliak.com   
Principal Investigator: Rebecca McDorman, BS         
Sub-Investigator: Heather Garcia, BS         
Sub-Investigator: Corinne Worland, AA         
Sub-Investigator: Jordyn Shubin         
Sponsors and Collaborators
California State Polytechnic University, Pomona
Investigators
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Study Director: Bonny Burns-Whitmore, DrPH, RD Cal Poly Pomona
Study Chair: David M Oliak, MD Oliak Center for Weight Loss
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Responsible Party: Rebecca McDorman, Graduate Student, California State Polytechnic University, Pomona
ClinicalTrials.gov Identifier: NCT02686905    
Other Study ID Numbers: VitaBari Study
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium, Dietary
Vitamin D
Vitamins
Hydroxocobalamin
Vitamin B 12
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Hematinics
Vitamin B Complex