Bariatric Surgery Candidate, Mineral Deficiency, Vitamin Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPatch 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.
Sponsors
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with deficiencies | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thiamine | 1 year | The average decrease in the serum concentration among all subjects |
| Pyridoxine | 1 year | The average decrease in the serum concentration among all subjects |
| Methylcobalamin | 1 year | The average decrease in the serum concentration among all subjects |
| Folate | 1 year | The average decrease in the serum concentration among all subjects |
| Zinc | 1 year | The average decrease in the serum concentration among all subjects |
| Calcium | 1 year | The average decrease in the serum concentration among all subjects |
| Copper | 1 year | The average decrease in the serum concentration among all subjects |
| Iron | 1 year | The average decrease in the serum concentration among all subjects |
| Vitamin D | 1 year | The average decrease in the serum concentration among all subjects |
| Parathyroid hormone | 1 year | The average decrease in the serum concentration among all subjects |
| Total iron binding capacity | 1 year | The average decrease among all subjects |
| Constipation syndrome | 1 year | 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. |
| Diarrhea syndrome | 1 year | 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. |
| Indigestion syndrome | 1 year | 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. |
| Acid reflux syndrome | 1 year | 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. |
| Abdominal pain syndrome | 1 year | 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. |
| Ferritin | 1 year | The average decrease in the serum concentration among all subjects |
Countries
United States
Outcome results
None listed