Vitamin Supplementation After Bariatric Surgery

Not Applicable

• Conditions: Complications of Bariatric Procedures; Avitaminosis

• 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

Primary Outcome Measures

Name	Time	Method
Vitamin B12 Blood Value	3 months	B12 (pg/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)
Weight Measurement	3 months	Weight (kg) via Tanita scale measurements
Waist Circumference	3 months	Waist circumference (cm)
Hip Circumference	3 months	Hip circumference (cm)
Iron Blood Value	3 months	Ferritin (ng/mL)
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