Vitamin A DeficiencyPhase 2FL-80NCT01381276
Vitamin A Absorption From Cassava in Women
A Phase 2 study testing Beta-Carotene bio-fortified cassava porridge without oil, Beta-Carotene bio-fortified cassava porridge with oil and White cassava porridge with retinyl palmitate reference dose in people with Vitamin A Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Beta-Carotene bio-fortified cassava porridge without oil, Beta-Carotene bio-fortified cassava porridge with oil and White cassava porridge with retinyl palmitate reference dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2011
- Phase
- Phase 2
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking
- BMI between 18-30
- total cholesterol concentrations between 90 and 225 mg/dL
- blood pressure under 140/90 mm Hg
- hemoglobin above 11.5 g/dL
- blood chemistries within the normal range
Who cannot join
- must not be pregnant or trying to get pregnant
- must not be taking fat, triacylglycerol, or cholesterol lowering medications) such as orlistat, gemfibrozil, niacin, lovastatin, simvastatin, colestipol, and ezetimibe)
- must not taking medicines containing high doses of retinoids such as Accutane or high vitamin A or carotenoid supplements
- must not have blood chemistry or health history results consistent with acute cancer or heart disease
- no obvious psychological or sociological problems such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an informed consent agreement or to participate in study duties and activities
- must not be allergic to cassava, peanuts, or peanut oil
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Center, University of California Davis
Davis, California, 95616
About this study
Official title: Vitamin A Equivalence of Carotenoids From Cassava in Women
The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava.
Read the detailed description
We plan to conduct a single site intervention phase II intervention study in healthy adult women. Women will serve as their own controls, and will be fed three treatments in random order: a single meal of low-carotenoid cassava porridge with fat, a similar meal of bio-fortified cassava (that is high in vitamin A-forming carotenoids) with fat, and a similar meal of bio-fortified cassava without fat. Carotenoids and vitamin A will be measured in the triacylglycerol-rich lipoprotein (TRL) fraction of plasma by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection. We plan to collect sufficient data to identify the times of the first appearance and peak concentrations in retinol, retinyl esters, alpha-carotene (AC), beta-carotene (BC), beta-carotene isomers (BCI), and cryptoxanthin (CX) in TRL: when a single meal containing moderately high amounts of carotenoids from bio-fortified cassava is fed to healthy adult women. We will use this data to determine the vitamin A equivalency of bio-fortified cassava in adult women, and the effect of fat on vitamin A equivalency of bio-fortified cassava.
- Conditions
- Vitamin A Deficiency
- Being tested
- Beta-Carotene bio-fortified cassava porridge without oil, Beta-Carotene bio-fortified cassava porridge with oil, White cassava porridge with retinyl palmitate reference dose
- Keywords
- 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.
Beta-Carotene bio-fortified cassava porridge without oilOther
300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene.
Beta-Carotene bio-fortified cassava porridge with oilOther
300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene.
White cassava porridge with retinyl palmitate reference doseOther
300 g porridge containing 15 mL peanut oil, 100 g drained mashed cassava, and a tracer of approximately .3 mg pure food-grade retinyl palmitate.
| Study group | Role | What they receive |
|---|---|---|
| Cassava Treatment 1 | Experimental | Single meal containing bio-fortified, high carotenoid cassava without oil. Receives: Other: Beta-Carotene bio-fortified cassava porridge without oil |
| Cassava Treatment 2 | Experimental | Single meal containing bio-fortified, high carotenoid cassava with oil. Receives: Other: Beta-Carotene bio-fortified cassava porridge with oil |
| Cassava Treatment 3 | Active comparator | Single meal containing low carotenoid cassava with oil and retinyl palmitate. Receives: Other: White cassava porridge with retinyl palmitate reference dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A equivalency from varieties of cassava with and without oil
Vitamin A and other carotenoids will be measured in triacylglycerol rich lipoprotein fractions at 0, 60, 150, 240, 330, 420, 510, 600, and 1440 minutes after consumption of cassava containing meal.
Measured: 0, 60, 150, 240, 330, 420, 510, 600, 1440 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- HarvestPlus
- Responsible party
- Sponsor
- Investigators
- Betty J Burri, PhD, Principal investigator, WHNRC, ARS, University of California Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381276
- Sponsor's protocol ID
- WHNRC 223773-1
- Acronym
- FL-80
- Status last verified
- Dec 2011
- First submitted
- 22 Jun 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A Equivalence of Carotenoids From Cassava in Women
- ClinicalTrials.gov ID
- NCT01381276
- Acronym / sponsor ID
- FL-80 / WHNRC 223773-1
- Conditions
- Vitamin A Deficiency
- Keywords
- Vitamin A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- HarvestPlus
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Jun 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.
The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava.
Detailed description
We plan to conduct a single site intervention phase II intervention study in healthy adult women. Women will serve as their own controls, and will be fed three treatments in random order: a single meal of low-carotenoid cassava porridge with fat, a similar meal of bio-fortified cassava (that is high in vitamin A-forming carotenoids) with fat, and a similar meal of bio-fortified cassava without fat. Carotenoids and vitamin A will be measured in the triacylglycerol-rich lipoprotein (TRL) fraction of plasma by standard methods involving ultracentrifugation (to concentrate the TRL fraction) followed by reversed-phase HPLC using electrochemical detection. We plan to collect sufficient data to identify the times of the first appearance and peak concentrations in retinol, retinyl esters, alpha-carotene (AC), beta-carotene (BC), beta-carotene isomers (BCI), and cryptoxanthin (CX) in TRL: when a single meal containing moderately high amounts of carotenoids from bio-fortified cassava is fed to healthy adult women. We will use this data to determine the vitamin A equivalency of bio-fortified cassava in adult women, and the effect of fat on vitamin A equivalency of bio-fortified cassava.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cassava Treatment 1 | Experimental | Other: Beta-Carotene bio-fortified cassava porridge without oilSingle meal containing bio-fortified, high carotenoid cassava without oil. |
| Cassava Treatment 2 | Experimental | Other: Beta-Carotene bio-fortified cassava porridge with oilSingle meal containing bio-fortified, high carotenoid cassava with oil. |
| Cassava Treatment 3 | Active comparator | Other: White cassava porridge with retinyl palmitate reference doseSingle meal containing low carotenoid cassava with oil and retinyl palmitate. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- non-smoking
- BMI between 18-30
- total cholesterol concentrations between 90 and 225 mg/dL
- blood pressure under 140/90 mm Hg
- hemoglobin above 11.5 g/dL
Key exclusion criteria (6 listed)
- must not be pregnant or trying to get pregnant
- must not be taking fat, triacylglycerol, or cholesterol lowering medications) such as orlistat, gemfibrozil, niacin, lovastatin, simvastatin, colestipol, and ezetimibe)
- must not taking medicines containing high doses of retinoids such as Accutane or high vitamin A or carotenoid supplements
- must not have blood chemistry or health history results consistent with acute cancer or heart disease
- no obvious psychological or sociological problems such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an informed consent agreement or to participate in study duties and activities
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 |
|---|---|---|
| Beta-Carotene bio-fortified cassava porridge without oil300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene. | Other | Cassava Treatment 1 |
| Beta-Carotene bio-fortified cassava porridge with oil300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene. | Other | Cassava Treatment 2 |
| White cassava porridge with retinyl palmitate reference dose300 g porridge containing 15 mL peanut oil, 100 g drained mashed cassava, and a tracer of approximately .3 mg pure food-grade retinyl palmitate. | Other | Cassava Treatment 3 |
Primary outcome
Vitamin A equivalency from varieties of cassava with and without oil
Time frame: 0, 60, 150, 240, 330, 420, 510, 600, 1440 min
Vitamin A and other carotenoids will be measured in triacylglycerol rich lipoprotein fractions at 0, 60, 150, 240, 330, 420, 510, 600, and 1440 minutes after consumption of cassava containing meal.
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 12 Dec 2011.
- USDA Western Human Nutrition Research CenterLink provided by the sponsor.
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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.
Betty J Burri, PhD principal investigator
WHNRC, ARS, University of California Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beta-Carotene bio-fortified cassava porridge without oil, Beta-Carotene bio-fortified cassava porridge with oil and White cassava porridge with retinyl palmitate reference dose in people with Vitamin A Deficiency, run by USDA, Western Human Nutrition Research Center 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 6 inclusion and 6 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 12 Dec 2011. 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 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.
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?
Vitamin A equivalency from varieties of cassava with and without oil (time frame: 0, 60, 150, 240, 330, 420, 510, 600, 1440 min). 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 12 Dec 2011.