Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2021-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin Supplementation After Bariatric Surgery

NCT02686905

Complications of Bariatric Procedures Avitaminosis

UNKNOWN NA

Vitamin and Mineral Supplementation Post Bariatric Surgery

NCT02817256

Complications of Other Bariatric Procedure

UNKNOWN NA

Supplementation After Bariatric Surgery

NCT04412421

Bariatric Surgery Micronutrient Deficiencies Obesity

UNKNOWN

Multivitamin Adherence Following Bariatric Surgery

NCT02124889

Obesity

COMPLETED NA

Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients

NCT01385098

Obesity Vitamin D Deficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bariatric Surgery Candidate Vitamin Deficiency Mineral Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Patch MD MultiVitamin Plus patch

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes