Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

Bariatric Surgery Candidate Clinical Trial

Official title:

Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360435
• Other study ID #: IRB201701809
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Avitaminosis
• Bariatric Surgery Candidate
• Mineral Deficiency
• Vitamin Deficiency

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