Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

Completed

• Conditions: Mineral Deficiency; Bariatric Surgery Candidate; Vitamin Deficiency
• Interventions: Dietary Supplement: Patch MD MultiVitamin Plus patch

• Registration Number: NCT03360435
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-04
• Study Start: 2017-12-15
• Status Verified: 2021-07
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with transdermal patches	Patch MD MultiVitamin Plus patch	All study subjects will belong to the same group. This group will undergo bariatric surgery and will use a transdermal patch for vitamin and mineral supplementation post operatively. The transdermal patch will be the Patch MD MultiVitamin Plus patch

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.
Methylcobalamin	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
Calcium	1 year	The average decrease in the serum concentration among all subjects
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.
Ferritin	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
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
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.
Total iron binding capacity	1 year	The average decrease among all subjects

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States