Vitamin Supplementation After Bariatric Surgery
Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 4, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedSeptember 30, 2016
September 1, 2016
1.4 years
February 4, 2016
September 29, 2016
Conditions
Outcome Measures
Primary Outcomes (11)
Fasting Blood Glucose
Glucose (mg/dL)
3 months
Calcium Blood Value
Calcium (mg/dL)
3 months
Iron Blood Value
Ferritin (ng/mL)
3 months
Vitamin B12 Blood Value
B12 (pg/mL)
3 months
Vitamin D Blood Value
Vitamin D, 25-Hydroxy (pg/mL)
3 months
HbA1c Blood Value
Hemoglobin A1c (%)
3 months
Fat Mass Measurement
Fat Mass (kg) via Tanita scale measurements
3 months
Fat Free Mass Measurement
Fat Free Mass (kg) via Tanita scale measurements
3 months
Weight Measurement
Weight (kg) via Tanita scale measurements
3 months
Waist Circumference
Waist circumference (cm)
3 months
Hip Circumference
Hip circumference (cm)
3 months
Secondary Outcomes (2)
Height
3 months
Total Body Water
3 months
Study Arms (2)
Topical vitamin patch
EXPERIMENTALDietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch
Oral vitamins
EXPERIMENTALDietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12
Interventions
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.
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.
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.
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.
Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
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.
Eligibility Criteria
You may qualify if:
- patients currently approved for vertical sleeve or gastric bypass bariatric surgery
- female patients should not be pregnant or plan to become pregnant
You may not qualify if:
- metal objects in the body
- current weight greater than 600lbs
- previous bariatric (revision) surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oliak Center for Weight Loss
Brea, California, 92821, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bonny Burns-Whitmore, DrPH, RD
Cal Poly Pomona
- STUDY CHAIR
David M Oliak, MD
Oliak Center for Weight Loss
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Graduate Student
Study Record Dates
First Submitted
February 4, 2016
First Posted
February 22, 2016
Study Start
January 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
September 30, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share