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Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

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ClinicalTrials.gov Identifier: NCT03360435
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Bariatric Surgery Candidate Vitamin Deficiency Mineral Deficiency Dietary Supplement: Patch MD MultiVitamin Plus 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : November 18, 2019
Estimated Study Completion Date : November 18, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants with transdermal patches
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
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.




Primary Outcome Measures :
  1. Percentage of subjects with deficiencies [ Time Frame: 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 :
  1. Thiamine [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  2. Pyridoxine [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  3. Methylcobalamin [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  4. Vitamin D [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  5. Folate [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  6. Zinc [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  7. Calcium [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  8. Copper [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  9. Iron [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  10. Ferritin [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  11. Parathyroid hormone [ Time Frame: 1 year ]
    The average decrease in the serum concentration among all subjects

  12. Total iron binding capacity [ Time Frame: 1 year ]
    The average decrease among all subjects

  13. Constipation syndrome [ Time Frame: 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.

  14. Diarrhea syndrome [ Time Frame: 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.

  15. Indigestion syndrome [ Time Frame: 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.

  16. Acid reflux syndrome [ Time Frame: 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.

  17. Abdominal pain syndrome [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing bariatric surgery for weight loss who have chosen to use a transdermal patch for vitamin and mineral supplementation will be recruited to complete the study. All eligible patients within the institution will be recruited.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360435


Contacts
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Contact: Jeffrey E Friedman, MD (352) 594-5117 Jeffrey.Friedman@surgery.ufl.edu
Contact: Tyler Culpepper, PhD (352) 406-4369 tygerguy@ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Jeffrey E Friedman, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03360435     History of Changes
Other Study ID Numbers: IRB201701809
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs