An observational study in Bariatric Surgery Candidate, Vitamin Deficiency and Mineral Deficiency, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-09.
Sponsored by University of Florida · Observational
Among 14 studies in Avitaminosis with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Avitaminosis · United States.
Among the 14 studies in Avitaminosis with a site in United States, this one is the only one that started in 2017, is the only observational one, and was the 9th registered.
35 studies on the registry are indexed under Avitaminosis; 3 are open to participants now.
Browse Avitaminosis studies →1 of the 14 studies in Avitaminosis with a site in United States is open now. Recruiting first, the newest first:
Madigan Army Medical Center · Sites in United States
Ages 18–69 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 2 Avitaminosis studies recruiting now, none set no upper age limit and 2 stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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14 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 99 is below the median of 327 across 10 observational studies indexed under Avitaminosis.
Median enrollment 96 across the 13 interventional studies, 99 across the 1 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
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1 of 14 have an industry lead sponsor. The 10 most frequent:
University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
University of Florida has 1 study filed under Avitaminosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Avitaminosis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 1 year
Thiamine
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Pyridoxine
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Methylcobalamin
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Vitamin D
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Folate
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Zinc
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Calcium
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Copper
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Iron
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Ferritin
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Parathyroid hormone
The average decrease in the serum concentration among all subjects
Time frame: 1 year
Total iron binding capacity
The average decrease among all subjects
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: No
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Ran from Dec 2017 to primary completion in Jul 2021, 42 months.
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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