Vitamin A DeficiencyNCT02702622
Vitamin A Equivalence of the Provitamin A in Biofortified Bananas
A study testing Provitamin A-biofortified transgenic bananas in people with Vitamin A Deficiency, run by Iowa State University.
Trial summary
The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Provitamin A-biofortified transgenic bananas
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2016
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health as determined by interview, blood biochemistry profile, and complete blood count
- Antecubital veins amenable to blood collection
Who cannot join
- Adverse reactions to blood sample collection
- History of anemia or excessive bleeding
- Cigarette smoking, frequent alcohol consumption
- Use of vitamin/mineral supplements
- Food allergies
- Lactose intolerance
Show all 13Show fewer
- Abnormal thyroid status
- Chronic disease, lipid malabsorption or gastrointestinal disorders
- Hyper- or hypolipidemia
- Body mass index (BMI) > 28
- History of eating disorder or restrained eating
- Current or planned pregnancy; menstrual cycle irregularities or abnormalities
- Use of hormonal contraceptives (affects chylomicron clearance); use of medications that may affect lipid absorption or transport
About this study
The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas.
- Conditions
- Vitamin A Deficiency
- Being tested
- Provitamin A-biofortified transgenic bananas
- Keywords
- bananas, biofortified, carotenoids, vitamin A
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provitamin A-biofortified transgenic bananasOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction
Measured: 0 - 9.5 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A DeficiencyStudies 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
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy S. White, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702622
- Sponsor's protocol ID
- 13-376
- Status last verified
- Aug 2016
- First submitted
- 3 Mar 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A Equivalence of the Provitamin A in Biofortified Bananas
- ClinicalTrials.gov ID
- NCT02702622
- Acronym / sponsor ID
- 13-376
- Conditions
- Vitamin A Deficiency
- Keywords
- bananas, biofortified, carotenoids, vitamin A
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- First posted
- 8 Mar 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 objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas.
Study design
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- General good health as determined by interview, blood biochemistry profile, and complete blood count
- Antecubital veins amenable to blood collection
Key exclusion criteria (13 listed)
- Adverse reactions to blood sample collection
- History of anemia or excessive bleeding
- Cigarette smoking, frequent alcohol consumption
- Use of vitamin/mineral supplements
- Food allergies
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 |
|---|---|---|
| Provitamin A-biofortified transgenic bananas | Other | – |
Primary outcome
Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction
Time frame: 0 - 9.5 hours postprandially
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 31 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Provitamin A-biofortified transgenic bananas in people with Vitamin A Deficiency, run by Iowa State University.
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 13 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction (time frame: 0 - 9.5 hours postprandially). 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 31 Aug 2016.