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Completed

NCT Number: NCT03360435

Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

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.

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Key information

Conditions

Bariatric Surgery Candidate Avitaminosis Deficiency Diseases Malnutrition Mineral Deficiency Nutrition Disorders Nutritional and Metabolic Diseases Vitamin Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidates for a sleeve gastrectomy or gastric bypass surgery
  • Willingness and ability to provide informed consent in English
  • Commitment to the 1 year study period

Exclusion criteria

  • Planned bariatric revision surgery
  • Patients with a left ventricular assistance device
  • Known End Stage Renal Disease
  • Known mutation in methylenetetrahydrofolate reductase (MTHFR) gene
  • Medical conditions requiring vitamin and mineral supplementation

Treatment and study plan

Patch MD MultiVitamin Plus patch

Dietary Supplement

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2017
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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