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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03360435
Other study ID # IRB201701809
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 15, 2017
Est. completion date July 7, 2021

Study information

Verified date July 2021
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date July 7, 2021
Est. primary completion date July 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
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.

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Secondary Thiamine The average decrease in the serum concentration among all subjects 1 year
Secondary Pyridoxine The average decrease in the serum concentration among all subjects 1 year
Secondary Methylcobalamin The average decrease in the serum concentration among all subjects 1 year
Secondary Vitamin D The average decrease in the serum concentration among all subjects 1 year
Secondary Folate The average decrease in the serum concentration among all subjects 1 year
Secondary Zinc The average decrease in the serum concentration among all subjects 1 year
Secondary Calcium The average decrease in the serum concentration among all subjects 1 year
Secondary Copper The average decrease in the serum concentration among all subjects 1 year
Secondary Iron The average decrease in the serum concentration among all subjects 1 year
Secondary Ferritin The average decrease in the serum concentration among all subjects 1 year
Secondary Parathyroid hormone The average decrease in the serum concentration among all subjects 1 year
Secondary Total iron binding capacity The average decrease among all subjects 1 year
Secondary 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. 1 year
Secondary 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. 1 year
Secondary 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. 1 year
Secondary 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. 1 year
Secondary 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. 1 year
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