Avitaminosis, Complications of Bariatric Procedures
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTChewable Multivitamin with Iron
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.
DIETARY_SUPPLEMENTPatchMD Vitamin D3/Calcium Patch
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.
DIETARY_SUPPLEMENTPatchMD Multivitamin Patch
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.
DIETARY_SUPPLEMENTPatchMD B12 Energy Plus Patch
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.
DIETARY_SUPPLEMENTChewable Calcium
Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
DIETARY_SUPPLEMENTQuick Dissolve B12
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.
Sponsors
California State Polytechnic University, Pomona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip Circumference | 3 months | Hip circumference (cm) |
| Weight Measurement | 3 months | Weight (kg) via Tanita scale measurements |
| Waist Circumference | 3 months | Waist circumference (cm) |
| Fasting Blood Glucose | 3 months | Glucose (mg/dL) |
| Calcium Blood Value | 3 months | Calcium (mg/dL) |
| Iron Blood Value | 3 months | Ferritin (ng/mL) |
| Vitamin B12 Blood Value | 3 months | B12 (pg/mL) |
| Vitamin D Blood Value | 3 months | Vitamin D, 25-Hydroxy (pg/mL) |
| HbA1c Blood Value | 3 months | Hemoglobin A1c (%) |
| Fat Mass Measurement | 3 months | Fat Mass (kg) via Tanita scale measurements |
| Fat Free Mass Measurement | 3 months | Fat Free Mass (kg) via Tanita scale measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Water | 3 months | Total body water (kg) via Tanita scale measurements |
| Height | 3 months | Statiometer measurement (cm) |
Countries
United States
Contacts
Primary ContactRebecca McDorman, BS
Outcome results
None listed