Clinical trial NCT03360435: Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients
Official title: Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Vitamin Deficiency
Mineral Deficiency
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects with deficiencies
timeFrame: 1 year
Secondary outcomes:
measure: Thiamine
timeFrame: 1 year
measure: Pyridoxine
timeFrame: 1 year
measure: Methylcobalamin
timeFrame: 1 year
measure: Vitamin D
timeFrame: 1 year
measure: Folate
timeFrame: 1 year
measure: Zinc
timeFrame: 1 year
measure: Calcium
timeFrame: 1 year
measure: Copper
timeFrame: 1 year
measure: Iron
timeFrame: 1 year
measure: Ferritin
timeFrame: 1 year
measure: Parathyroid hormone
timeFrame: 1 year
measure: Total iron binding capacity
timeFrame: 1 year
measure: Constipation syndrome
timeFrame: 1 year
measure: Diarrhea syndrome
timeFrame: 1 year
measure: Indigestion syndrome
timeFrame: 1 year
measure: Acid reflux syndrome
timeFrame: 1 year
measure: Abdominal pain syndrome
timeFrame: 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jeffrey E Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: