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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical vitamin patch | Experimental | Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch |
|
| Oral vitamins | Experimental | Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chewable Multivitamin with Iron | Dietary Supplement | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Statiometer measurement (cm) | 3 months |
| Total Body Water | Total body water (kg) via Tanita scale measurements | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca McDorman, BS | Contact | 9497023182 | rlmcdorman@cpp.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bonny Burns-Whitmore, DrPH, RD | Cal Poly Pomona | Study Director |
| David M Oliak, MD | Oliak Center for Weight Loss | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oliak Center for Weight Loss | Recruiting | Brea | California | 92821 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 3, 2018 | |
| Reset | Jan 14, 2019 |
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|
| PatchMD Vitamin D3/Calcium Patch | Dietary Supplement | 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. |
|
|
| PatchMD Multivitamin Patch | Dietary Supplement | 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. |
|
|
| PatchMD B12 Energy Plus Patch | Dietary Supplement | 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. |
|
|
| Chewable Calcium | Dietary Supplement | Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon. |
|
|
| Quick Dissolve B12 | Dietary Supplement | 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. |
|
|
| Waist Circumference |
Waist circumference (cm) |
| 3 months |
| Hip Circumference | Hip circumference (cm) | 3 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 3, 2018 | Jan 14, 2019 |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| ID | Term |
|---|---|
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007501 | Iron |
| D057968 | Transdermal Patch |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D004864 | Equipment and Supplies |
| D017610 | Calcium Compounds |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
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