Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

NCT03360435 | Completed

• 1 other identifier: IRB201701809
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery Candidate; Vitamin Deficiency; Mineral Deficiency

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with deficiencies

  The primary end point is the percentage of participants who have two or more deficiencies of vitamins B1, B6, B12, folate, D, zinc, calcium, copper, and iron one year after bariatric surgery after using the Patch MD™ MultiVitamin Plus transdermal patch for supplementation.

  1 year

Secondary Outcomes (17)

• Thiamine

  1 year

• Pyridoxine

  1 year

• Methylcobalamin

  1 year

• Vitamin D

  1 year

• Folate

  1 year

Study Arms (1)

Participants with transdermal patches

All study subjects will belong to the same group. This group will undergo bariatric surgery and will use a transdermal patch for vitamin and mineral supplementation post operatively. The transdermal patch will be the Patch MD MultiVitamin Plus patch

Dietary Supplement: Patch MD MultiVitamin Plus patch

Interventions

Patch MD MultiVitamin Plus patch DIETARY_SUPPLEMENT

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.

Participants with transdermal patches

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing bariatric surgery for weight loss who have chosen to use a transdermal patch for vitamin and mineral supplementation will be recruited to complete the study. All eligible patients within the institution will be recruited.

You may qualify if:

• Candidates for a sleeve gastrectomy or gastric bypass surgery
• Willingness and ability to provide informed consent in English
• Commitment to the 1 year study period

You may not qualify if:

• Planned bariatric revision surgery
• Patients with a left ventricular assistance device
• Known End Stage Renal Disease
• Known mutation in methylenetetrahydrofolate reductase (MTHFR) gene
• Medical conditions requiring vitamin and mineral supplementation

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Avitaminosis

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Jeffrey E Friedman, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 4, 2017
• Study Start: December 15, 2017
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)