Vitamin Supplementation After Bariatric Surgery

Complications of Bariatric Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02686905
• Other study ID #: VitaBari Study
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2016
• Last updated: September 29, 2016
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: California State Polytechnic University, Pomona
• Contact: Rebecca McDorman, BS
• Phone: 9497023182
• Email: rlmcdorman[@]cpp.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avitaminosis
• Complications of Bariatric Procedures

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Oliak Center for Weight Loss	Brea	California

Sponsors (1)

Lead Sponsor	Collaborator
California State Polytechnic University, Pomona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Blood Glucose	Glucose (mg/dL)	3 months	Yes
Primary	Calcium Blood Value	Calcium (mg/dL)	3 months	Yes
Primary	Iron Blood Value	Ferritin (ng/mL)	3 months	Yes
Primary	Vitamin B12 Blood Value	B12 (pg/mL)	3 months	Yes
Primary	Vitamin D Blood Value	Vitamin D, 25-Hydroxy (pg/mL)	3 months	Yes
Primary	HbA1c Blood Value	Hemoglobin A1c (%)	3 months	Yes
Primary	Fat Mass Measurement	Fat Mass (kg) via Tanita scale measurements	3 months	No
Primary	Fat Free Mass Measurement	Fat Free Mass (kg) via Tanita scale measurements	3 months	No
Primary	Weight Measurement	Weight (kg) via Tanita scale measurements	3 months	No
Primary	Waist Circumference	Waist circumference (cm)	3 months	No
Primary	Hip Circumference	Hip circumference (cm)	3 months	No
Secondary	Height	Statiometer measurement (cm)	3 months	No
Secondary	Total Body Water	Total body water (kg) via Tanita scale measurements	3 months	No