NCT03360435

Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Patients undergoing bariatric surgery often develop new vitamin and/or mineral deficiencies or exacerbate prior deficiencies after surgery. Several bariatric supplement products exist including oral tablets and transdermal patches. The purpose of this study is to observe the concentrations of serum micronutrients and determine how many deficiencies develop in patients who use a transdermal patch.

Detailed description

Patients will undergo either a sleeve gastrectomy or gastric bypass procedure. All patients enrolled will have previously chosen to use the Patch MD MultiVitamin Plus patch for vitamin and mineral supplementation versus oral or other dosage forms of vitamins after surgery. A conversation between the patient and provider will occur first during a pre operative appointment, at which time the patient will be presented with the option to use oral vitamins or the Patch MD MultiVitamin Plus patch after surgery. Only if the patient chooses the patch will he/she be made aware of the study and recruited. Pre operative blood draws will be used to determine baseline micronutrient serum concentrations and existing deficiencies. The Gastrointestinal Symptom Rating Scale (GSRS) will be used pre operatively to determine baseline gastrointestinal symptoms. Post operative blood draws and GSRS data will be collected at 3 months, 6 months, and 1 year after surgery.

Conditions

• Bariatric Surgery Candidate
• Vitamin Deficiency
• Mineral Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Patch MD MultiVitamin Plus patch	The transdermal patch contains vitamins A, D, E, K2, C, thiamine, riboflavin, niacin, pantothenic acid, pyridoxine, biotin, folic acid, cyanocobalamin, calcium, iron, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, potassium, chloride, and boron.

Timeline

• Start date: 2017-12-15
• Primary completion: 2021-07-07
• Completion: 2021-07-07
• First posted: 2017-12-04
• Last updated: 2021-07-09

Locations

1 site across 1 country: United States