Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/3/2018 |
| Start Date: | December 15, 2017 |
| End Date: | November 18, 2019 |
| Contact: | Jeffrey E Friedman, MD |
| Email: | Jeffrey.Friedman@surgery.ufl.edu |
| Phone: | (352) 594-5117 |
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.
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.
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.
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.
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
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