Vitamin Supplementation After Bariatric Surgery

Not Applicable

• Conditions: Complications of Bariatric Procedures; Avitaminosis
• Interventions: Dietary Supplement: Chewable Multivitamin with Iron; Dietary Supplement: PatchMD Vitamin D3/Calcium Patch; Dietary Supplement: Chewable Calcium; Dietary Supplement: PatchMD Multivitamin Patch; Dietary Supplement: Quick Dissolve B12; Dietary Supplement: PatchMD B12 Energy Plus Patch

• Registration Number: NCT02686905
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral vitamins	Chewable Calcium	Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12
Topical vitamin patch	PatchMD Multivitamin Patch	Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch
Oral vitamins	Chewable Multivitamin with Iron	Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12
Topical vitamin patch	PatchMD Vitamin D3/Calcium Patch	Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch
Oral vitamins	Quick Dissolve B12	Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12
Topical vitamin patch	PatchMD B12 Energy Plus Patch	Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch

Primary Outcome Measures

Name	Time	Method
Vitamin B12 Blood Value	3 months	B12 (pg/mL)
Iron Blood Value	3 months	Ferritin (ng/mL)
Vitamin D Blood Value	3 months	Vitamin D, 25-Hydroxy (pg/mL)
Fat Free Mass Measurement	3 months	Fat Free Mass (kg) via Tanita scale measurements
Fasting Blood Glucose	3 months	Glucose (mg/dL)
Calcium Blood Value	3 months	Calcium (mg/dL)
Waist Circumference	3 months	Waist circumference (cm)
Weight Measurement	3 months	Weight (kg) via Tanita scale measurements
Hip Circumference	3 months	Hip circumference (cm)
HbA1c Blood Value	3 months	Hemoglobin A1c (%)
Fat Mass Measurement	3 months	Fat Mass (kg) via Tanita scale measurements

Secondary Outcome Measures

Name	Time	Method
Height	3 months	Statiometer measurement (cm)
Total Body Water	3 months	Total body water (kg) via Tanita scale measurements

Trial Locations

Locations (1)

Oliak Center for Weight Loss; 🇺🇸 Brea, California, United States