Bariatric Surgery Candidate Clinical Trial
Official title:
Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients
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 |
Verified date | July 2021 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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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