Bariatric Surgery CandidatePhase 2/3NCT01475617
Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
A Phase 2/3 study testing AquaVanta Chewable Tablet, Flinstones Complete and Nature Made Calcium Softgels in people with Bariatric Surgery Candidate, run by Yasoo Health at 1 site in United States.
Trial summary
Approximately 33% of the US adult population can be classified as obese based on body mass index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed every year for the treatment of "clinically severe obesity". Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- AquaVanta Chewable Tablet, Flinstones Complete and Nature Made Calcium Softgels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2014
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 - 65 years of age
- Meet appropriate criteria for Roux-en-Y gastric bypass (RYGB) surgery as determined by the Principal Investigator at The John's Hopkins Center for Bariatric Surgery (JHCBS)
Who cannot join
- Allergy to a component of the formulations
- Recent (last 3 months) use of a dietary supplement other than a standard non-bariatric specific multivitamin supplement
- Documented levels of fat-soluble vitamins (A,D,E,K) or iron above the normal range
- Pregnant or lactating
- Expected poor compliance with medical regimen as assessed by JHCBS clinic care providers
Trial locations and contacts
1 site in 1 country.
United States1 site
The John's Hopkins Center for Bariatric Surgery (JHCBS)
Baltimore, Maryland, 21224-2780
About this study
Approximately 33% of the US adult population can be classified as obese based on body mass index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed every year for the treatment of "clinically severe obesity". Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed in the United States and has both restrictive and malabsorptive components. Despite the success of this procedure in creating long lasting weight loss, vitamin and iron deficiencies are common and can lead to significant morbidity if not appropriately addressed. Despite the American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic \& Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation recommendations, there has been very little prospective research conducted to assess the efficacy and compliance of these micronutrient interventions.
This prospective randomized controlled clinical study will evaluate the efficacy of a novel vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative bariatric patients.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- AquaVanta Chewable Tablet, Flinstones Complete, Nature Made Calcium Softgels, Twin Labs Iron Caps, Rexall Vitamin B12 Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaVanta Chewable TabletDietary supplement
AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months
Flinstones CompleteDietary supplement
Flinstones Complete Multivitamin 2 times a day for 6 months
Nature Made Calcium SoftgelsDietary supplement
Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
Nature Made Calcium SoftgelsDietary supplement
Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
Twin Labs Iron CapsDietary supplement
Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months
Rexall Vitamin B12 TabletDietary supplement
Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Novel Multivitamin/Mineral Supplement | Experimental | These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration. Receives: Dietary Supplement: AquaVanta Chewable Tablet; Dietary Supplement: Nature Made Calcium Softgels |
| Standard of care supplement | Active comparator | These subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration. Receives: Dietary Supplement: Flinstones Complete; Dietary Supplement: Nature Made Calcium Softgels; Dietary Supplement: Twin Labs Iron Caps; Dietary Supplement: Rexall Vitamin B12 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma vitamin and mineral levels
Measured: 3 and 6 months compared to baseline
Secondary outcomes (1)
Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasoo Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberley Steele Steele, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475617
- Sponsor's protocol ID
- AQV-001
- Status last verified
- Jan 2015
- First submitted
- 7 Nov 2011
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Perin J, Prokopowicz G, Furtado M, Papas K, Steele KE. A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass. Obes Surg. 2018 Aug;28(8):2406-2420. doi: 10.1007/s11695-018-3177-0.
PubMed 29500675
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
- ClinicalTrials.gov ID
- NCT01475617
- Acronym / sponsor ID
- AQV-001
- Conditions
- Bariatric Surgery Candidate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Yasoo HealthIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Nov 2011 (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.
Approximately 33% of the US adult population can be classified as obese based on body mass index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed every year for the treatment of "clinically severe obesity". Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed in the United States and has both restrictive and malabsorptive components. Despite the success of this procedure in creating long lasting weight loss, vitamin and iron deficiencies are common and can lead to significant morbidity if not appropriately addressed. Despite the American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic \& Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation recommendations, there has been very little prospective research conducted to assess the efficacy and compliance of these micronutrient interventions.
This prospective randomized controlled clinical study will evaluate the efficacy of a novel vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative bariatric patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel Multivitamin/Mineral Supplement | Experimental | Dietary Supplement: AquaVanta Chewable Tablet, Dietary Supplement: Nature Made Calcium SoftgelsThese subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration. |
| Standard of care supplement | Active comparator | Dietary Supplement: Flinstones Complete, Dietary Supplement: Nature Made Calcium Softgels, Dietary Supplement: Twin Labs Iron Caps, Dietary Supplement: Rexall Vitamin B12 TabletThese subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 - 65 years of age
- Meet appropriate criteria for Roux-en-Y gastric bypass (RYGB) surgery as determined by the Principal Investigator at The John's Hopkins Center for Bariatric Surgery (JHCBS)
Key exclusion criteria (5 listed)
- Allergy to a component of the formulations
- Recent (last 3 months) use of a dietary supplement other than a standard non-bariatric specific multivitamin supplement
- Documented levels of fat-soluble vitamins (A,D,E,K) or iron above the normal range
- Pregnant or lactating
- Expected poor compliance with medical regimen as assessed by JHCBS clinic care providers
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 |
|---|---|---|
| AquaVanta Chewable TabletAquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months | Dietary supplement | Novel Multivitamin/Mineral Supplement |
| Flinstones CompleteFlinstones Complete Multivitamin 2 times a day for 6 months | Dietary supplement | Standard of care supplement |
| Nature Made Calcium SoftgelsNature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months | Dietary supplement | Novel Multivitamin/Mineral Supplement |
| Nature Made Calcium SoftgelsNature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months | Dietary supplement | Standard of care supplement |
| Twin Labs Iron CapsTwin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months | Dietary supplement | Standard of care supplement |
| Rexall Vitamin B12 TabletRexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months | Dietary supplement | Standard of care supplement |
Primary outcome
Plasma vitamin and mineral levels
Time frame: 3 and 6 months compared to baseline
1 secondary outcome
Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- Derived from this study: PubMed 29500675Perin J, Prokopowicz G, Furtado M, Papas K, Steele KE. A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass. Obes Surg. 2018 Aug;28(8):2406-2420. doi: 10.1007/s11695-018-3177-0.
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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.
Kimberley Steele Steele, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AquaVanta Chewable Tablet, Flinstones Complete and Nature Made Calcium Softgels in people with Bariatric Surgery Candidate, run by Yasoo Health 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 5 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: finished, as of the sponsor's last update on 22 Jan 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma vitamin and mineral levels (time frame: 3 and 6 months compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01475617, which also lists 1 linked publication.
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 22 Jan 2015.