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.
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.
Study Type
OBSERVATIONAL
Enrollment
99
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.
University of Florida
Gainesville, Florida, United States
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.
Time frame: 1 year
Thiamine
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Pyridoxine
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Methylcobalamin
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Vitamin D
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Folate
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Zinc
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Calcium
The average decrease in the serum concentration among all subjects
Time frame: 1 year
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Copper
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Iron
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Ferritin
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Parathyroid hormone
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Total iron binding capacity
The average decrease among all subjects
Time frame: 1 year
Constipation syndrome
The average increase among all subjects using the Gastrointestinal Symptom Rating Scale. For constipation syndrome, three symptoms (constipation, hard stools, feeling of incomplete evacuation) will each be measured on a seven point Likert scale (0=no symptom, 6=most severe symptom). The three values will be averaged to provide one value which will represent constipation syndrome.
Time frame: 1 year
Diarrhea syndrome
The average increase among all subjects using the Gastrointestinal Symptom Rating Scale. For diarrhea syndrome, three symptoms (diarrhea, loose stools, urgent need for defecation) will each be measured on a seven point Likert scale (0=no symptom, 6=most severe symptom). The three values will be averaged to provide one value which will represent diarrhea syndrome.
Time frame: 1 year
Indigestion syndrome
The average increase among all subjects using the Gastrointestinal Symptom Rating Scale. For indigestion syndrome, five symptoms (nausea, stomach rumbling, feeling bloated, burping, and passing gas) will each be measured on a seven point Likert scale (0=no symptom, 6=most severe symptom). The five values will be averaged to provide one value which will represent indigestion syndrome.
Time frame: 1 year
Acid reflux syndrome
The average increase among all subjects using the Gastrointestinal Symptom Rating Scale. For acid reflux syndrome, two symptoms (heart burn and acid reflux) will each be measured on a seven point Likert scale (0=no symptom, 6=most severe symptom). The two values will be averaged to provide one value which will represent acid reflux syndrome.
Time frame: 1 year
Abdominal pain syndrome
The average increase among all subjects using the Gastrointestinal Symptom Rating Scale. For abdominal pain syndrome, two symptoms (stomach ache and hunger pains) will each be measured on a seven point Likert scale (0=no symptom, 6=most severe symptom). The two values will be averaged to provide one value which will represent abdominal pain syndrome.
Time frame: 1 year