Vitamin A Equivalence of the Provitamin A in Biofortified... | NCT02702622

Studies
Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

NCT02702622

Sponsor

Iowa State University

Status

Completed

Last Update Posted

Aug 31, 2016Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Vitamin A Deficiency

Interventions

Provitamin A-biofortified transgenic bananas

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Not provided

First Submitted Date

Mar 3, 2016

First Submission Date that Met QC Criteria

Mar 7, 2016

First Posted Date

Mar 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2016

Last Update Posted Date

Aug 31, 2016Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Provitamin A-biofortified transgenic bananas	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve for retinyl ester in the plasma triacylglycerol-rich lipoprotein fraction		0 - 9.5 hours postprandially

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

General good health as determined by interview, blood biochemistry profile, and complete blood count
Antecubital veins amenable to blood collection

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014802	Vitamin A Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided