Vitamin Supplementation After Bariatric Surgery

Study Overview
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Brief Summary
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The objectives in this study are to provide information on the efficacy of transdermal supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric patients, and to determine short-term body composition, HbA1c and fasting plasma glucose outcomes for patients after bariatric surgery.

Official Title
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Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery

Conditions
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Complications of Bariatric Procedures, Avitaminosis

Intervention / Treatment
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* Dietary Supplement: Chewable Multivitamin with Iron
* Dietary Supplement: PatchMD Vitamin D3/Calcium Patch
* Dietary Supplement: PatchMD Multivitamin Patch
* Dietary Supplement: PatchMD B12 Energy Plus Patch
* Dietary Supplement: Chewable Calcium
* Dietary Supplement: Quick Dissolve B12


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients currently approved for vertical sleeve or gastric bypass bariatric surgery female patients should not be pregnant or plan to become pregnant Exclusion Criteria: metal objects in the body current weight greater than 600lbs previous bariatric (revision) surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical vitamin patch<br>Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch | Dietary Supplement: PatchMD Vitamin D3/Calcium Patch<br>* Wear daily: PatchMD Vitamin D3/Calcium patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.<br>* Other names: Transdermal Vitamin Supplementation;Dietary Supplement: PatchMD Multivitamin Patch<br>* Wear daily: PatchMD Multivitamin patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.<br>* Other names: Transdermal Vitamin Supplementation;Dietary Supplement: PatchMD B12 Energy Plus Patch<br>* Wear daily: PatchMD B12 Energy Plus patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.<br>* Other names: Transdermal Vitamin Supplementation;|
| Experimental: Oral vitamins<br>Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12 | Dietary Supplement: Chewable Multivitamin with Iron<br>* Take daily: Chewable Multivitamin with Iron. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.<br>* Other names: Oral Vitamin Supplementation;Dietary Supplement: Chewable Calcium<br>* Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.<br>* Other names: Oral Vitamin Supplementation;Dietary Supplement: Quick Dissolve B12<br>* Take daily: Quick Dissolve B12. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.<br>* Other names: Oral Vitamin Supplementation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Glucose | Glucose (mg/dL) | 3 months | 
| Calcium Blood Value | Calcium (mg/dL) | 3 months | 
| Iron Blood Value | Ferritin (ng/mL) | 3 months | 
| Vitamin B12 Blood Value | B12 (pg/mL) | 3 months | 
| Vitamin D Blood Value | Vitamin D, 25-Hydroxy (pg/mL) | 3 months | 
| HbA1c Blood Value | Hemoglobin A1c (%) | 3 months | 
| Fat Mass Measurement | Fat Mass (kg) via Tanita scale measurements | 3 months | 
| Fat Free Mass Measurement | Fat Free Mass (kg) via Tanita scale measurements | 3 months | 
| Weight Measurement | Weight (kg) via Tanita scale measurements | 3 months | 
| Waist Circumference | Waist circumference (cm) | 3 months | 
| Hip Circumference | Hip circumference (cm) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Statiometer measurement (cm) | 3 months | 
| Total Body Water | Total body water (kg) via Tanita scale measurements | 3 months |