Complications of Bariatric ProceduresNCT02686905
Vitamin Supplementation After Bariatric Surgery
A study testing Chewable Multivitamin with Iron, PatchMD Vitamin D3/Calcium Patch and PatchMD Multivitamin Patch in people with Complications of Bariatric Procedures and Avitaminosis, run by California State Polytechnic University, Pomona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Complications of Bariatric Procedures, Avitaminosis
- What is being tested?
- Chewable Multivitamin with Iron, PatchMD Vitamin D3/Calcium Patch and PatchMD Multivitamin Patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients currently approved for vertical sleeve or gastric bypass bariatric surgery
- female patients should not be pregnant or plan to become pregnant
Who cannot join
- metal objects in the body
- current weight greater than 600lbs
- previous bariatric (revision) surgery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oliak Center for Weight Loss
Brea, California, 92821
David Oliak, MD, 714-582-2530, info@droliak.com
Rebecca McDorman, BS
About this study
Official title: Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery
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.
- Being tested
- Chewable Multivitamin with Iron, PatchMD Vitamin D3/Calcium Patch, PatchMD Multivitamin Patch, PatchMD B12 Energy Plus Patch, Chewable Calcium
- Medical subject headings
- Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewable Multivitamin with IronDietary supplement
Also called Oral Vitamin Supplementation
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.
PatchMD Vitamin D3/Calcium PatchDietary supplement
Also called Transdermal Vitamin Supplementation
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 PatchDietary supplement
Also called Transdermal Vitamin Supplementation
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 PatchDietary supplement
Also called Transdermal Vitamin Supplementation
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 CalciumDietary supplement
Also called Oral Vitamin Supplementation
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 B12Dietary supplement
Also called Oral Vitamin Supplementation
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.
| Study group | Role | What they receive |
|---|---|---|
| Topical vitamin patch | Experimental | Dietary Supplement: PatchMD Vitamin D3/Calcium Patch Dietary Supplement: PatchMD Multivitamin Patch Dietary Supplement: PatchMD B12 Energy Plus Patch Receives: 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 Receives: Dietary Supplement: Chewable Multivitamin with Iron; Dietary Supplement: Chewable Calcium; Dietary Supplement: Quick Dissolve B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
Glucose (mg/dL)
Measured: 3 months
Calcium Blood Value
Calcium (mg/dL)
Measured: 3 months
Iron Blood Value
Ferritin (ng/mL)
Measured: 3 months
Vitamin B12 Blood Value
B12 (pg/mL)
Measured: 3 months
Vitamin D Blood Value
Vitamin D, 25-Hydroxy (pg/mL)
Measured: 3 months
HbA1c Blood Value
Hemoglobin A1c (%)
Measured: 3 months
Fat Mass Measurement
Fat Mass (kg) via Tanita scale measurements
Measured: 3 months
Fat Free Mass Measurement
Fat Free Mass (kg) via Tanita scale measurements
Measured: 3 months
Weight Measurement
Weight (kg) via Tanita scale measurements
Measured: 3 months
Waist Circumference
Waist circumference (cm)
Measured: 3 months
Hip Circumference
Hip circumference (cm)
Measured: 3 months
Secondary outcomes (2)
Height
Statiometer measurement (cm)
Measured: 3 months
Total Body Water
Total body water (kg) via Tanita scale measurements
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of Bariatric ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State Polytechnic University, Pomona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca McDorman, California State Polytechnic University, Pomona
- Investigators
- Bonny Burns-Whitmore, DrPH, RD, Study director, Cal Poly PomonaDavid M Oliak, MD, Study chair, Oliak Center for Weight Loss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686905
- Sponsor's protocol ID
- VitaBari Study
- Status last verified
- Sep 2016
- First submitted
- 4 Feb 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02686905
- Acronym / sponsor ID
- VitaBari Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- California State Polytechnic University, PomonaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical vitamin patch | Experimental | Dietary Supplement: PatchMD Vitamin D3/Calcium Patch, Dietary Supplement: PatchMD Multivitamin Patch, Dietary Supplement: PatchMD B12 Energy Plus PatchDietary 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 B12Dietary Supplement: Chewable Multivitamin with Iron Dietary Supplement: Chewable Calcium Dietary Supplement: Quick Dissolve B12 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients currently approved for vertical sleeve or gastric bypass bariatric surgery
- female patients should not be pregnant or plan to become pregnant
Key exclusion criteria (3 listed)
- metal objects in the body
- current weight greater than 600lbs
- previous bariatric (revision) surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewable Multivitamin with IronAlso: Oral Vitamin SupplementationTake 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 supplement | Oral vitamins |
| PatchMD Vitamin D3/Calcium PatchAlso: Transdermal Vitamin SupplementationWear 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 supplement | Topical vitamin patch |
| PatchMD Multivitamin PatchAlso: Transdermal Vitamin SupplementationWear 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 supplement | Topical vitamin patch |
| PatchMD B12 Energy Plus PatchAlso: Transdermal Vitamin SupplementationWear 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 supplement | Topical vitamin patch |
| Chewable CalciumAlso: Oral Vitamin SupplementationTake daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon. | Dietary supplement | Oral vitamins |
| Quick Dissolve B12Also: Oral Vitamin SupplementationTake daily: Quick Dissolve B12. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon. | Dietary supplement | Oral vitamins |
Primary outcome
Fasting Blood Glucose
Time frame: 3 months
Glucose (mg/dL)
Calcium Blood Value
Time frame: 3 months
Calcium (mg/dL)
Iron Blood Value
Time frame: 3 months
Ferritin (ng/mL)
Vitamin B12 Blood Value
Time frame: 3 months
B12 (pg/mL)
Vitamin D Blood Value
Time frame: 3 months
Vitamin D, 25-Hydroxy (pg/mL)
HbA1c Blood Value
Time frame: 3 months
Hemoglobin A1c (%)
Fat Mass Measurement
Time frame: 3 months
Fat Mass (kg) via Tanita scale measurements
Fat Free Mass Measurement
Time frame: 3 months
Fat Free Mass (kg) via Tanita scale measurements
Weight Measurement
Time frame: 3 months
Weight (kg) via Tanita scale measurements
Waist Circumference
Time frame: 3 months
Waist circumference (cm)
Hip Circumference
Time frame: 3 months
Hip circumference (cm)
2 secondary outcomes
Height
Time frame: 3 months
Total Body Water
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonny Burns-Whitmore, DrPH, RD study director
Cal Poly Pomona
David M Oliak, MD study chair
Oliak Center for Weight Loss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewable Multivitamin with Iron, PatchMD Vitamin D3/Calcium Patch and PatchMD Multivitamin Patch in people with Complications of Bariatric Procedures and Avitaminosis, run by California State Polytechnic University, Pomona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca McDorman, BS (9497023182, rlmcdorman@cpp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (time frame: 3 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.