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Status unknownNCT02686905Updated Sep 30, 2016

Vitamin Supplementation After Bariatric Surgery

An interventional study of Chewable Multivitamin with Iron and PatchMD Vitamin D3/Calcium Patch in Complications of Bariatric Procedures and Avitaminosis, sponsored by California State Polytechnic University, Pomona. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-30.

Sponsored by California State Polytechnic University, Pomona · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Complications of Bariatric Procedures
  • Avitaminosis

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03

In context

Avitaminosis

102 studies on the registry are indexed under Avitaminosis; 7 are open to participants now.

This study's planned enrollment of 30 is below the median of 69 across 74 interventional studies indexed under Avitaminosis.

Browse Avitaminosis studies →

Lead sponsor

California State Polytechnic University, Pomona is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • metal objects in the body
  • current weight greater than 600lbs
  • previous bariatric (revision) surgery
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Topical vitamin patch

    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 · Dietary Supplement: PatchMD Multivitamin Patch · Dietary Supplement: PatchMD B12 Energy Plus Patch

  • Experimental
    Oral vitamins

    Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12

    Dietary Supplement: Chewable Multivitamin with Iron · Dietary Supplement: Chewable Calcium · Dietary Supplement: Quick Dissolve B12

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.

    Also known as: Oral Vitamin Supplementation

  • 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.

    Also known as: Transdermal Vitamin Supplementation

  • 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.

    Also known as: Transdermal Vitamin Supplementation

  • 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.

    Also known as: Transdermal Vitamin Supplementation

  • 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.

    Also known as: Oral Vitamin Supplementation

  • 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.

    Also known as: Oral Vitamin Supplementation

06

What researchers measure

Primary outcomes

  1. Fasting Blood Glucose

    Glucose (mg/dL)

    Time frame: 3 months

  2. Calcium Blood Value

    Calcium (mg/dL)

    Time frame: 3 months

  3. Iron Blood Value

    Ferritin (ng/mL)

    Time frame: 3 months

  4. Vitamin B12 Blood Value

    B12 (pg/mL)

    Time frame: 3 months

  5. Vitamin D Blood Value

    Vitamin D, 25-Hydroxy (pg/mL)

    Time frame: 3 months

  6. HbA1c Blood Value

    Hemoglobin A1c (%)

    Time frame: 3 months

  7. Fat Mass Measurement

    Fat Mass (kg) via Tanita scale measurements

    Time frame: 3 months

  8. Fat Free Mass Measurement

    Fat Free Mass (kg) via Tanita scale measurements

    Time frame: 3 months

  9. Weight Measurement

    Weight (kg) via Tanita scale measurements

    Time frame: 3 months

  10. Waist Circumference

    Waist circumference (cm)

    Time frame: 3 months

  11. Hip Circumference

    Hip circumference (cm)

    Time frame: 3 months

Secondary outcomes

  1. Height

    Statiometer measurement (cm)

    Time frame: 3 months

  2. Total Body Water

    Total body water (kg) via Tanita scale measurements

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Oliak Center for Weight Loss
    Brea, California 92821, United States
    • David Oliak, MD · Contact · info@droliak.com · 714-582-2530
    • Rebecca McDorman, BS · Principal investigator
    • Heather Garcia, BS · Sub investigator
    • Corinne Worland, AA · Sub investigator
    • Jordyn Shubin · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02686905
Lead sponsor
California State Polytechnic University, Pomona
Responsible party
Rebecca McDorman (Graduate Student, California State Polytechnic University, Pomona) — Principal investigator
First posted
Feb 22, 2016
Start date
Jan 2016
Primary completion
Jun 2017 (estimated)
Completion
Jun 2017 (estimated)
Last update
Sep 30, 2016

Study contacts

Rebecca McDorman, BS
Contact
rlmcdorman@cpp.edu
9497023182
Bonny Burns-Whitmore, DrPH, RD
study director · Cal Poly Pomona
David M Oliak, MD
study chair · Oliak Center for Weight Loss

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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