NCT01399164

Brief Summary

To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

3.7 years

First QC Date

July 19, 2011

Last Update Submit

October 21, 2013

Conditions

Vitamin B-12 DeficiencyAchlorhydria

Keywords

Vitamin B-12

Outcome Measures

Primary Outcomes (1)

  • B12 bioavailability

    B12 bioavailability from 14C-B12 fortified bread

    8 Days

Study Arms (1)

Fortified Bread

EXPERIMENTAL

A single serving of 14C-B12 fortified bread

Other: 14C-B12 fortified bread

Interventions

14C-B12 fortified breadOTHER

A single serving of 14C-B12 fortified bread

Fortified Bread

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • good overall health
  • normal absorptive capacity (controls) or with a serum B12 \<300 pg/mL and a pepsinogen I level \>100 μg/L (ACs).
  • All subjects must be available to complete the protocol

You may not qualify if:

  • Any chronic health disorder
  • Anemia of any kind
  • Renal insufficiency
  • excessive alcohol consumption
  • Prior GI surgery
  • Use of OTC or prescription drugs that interfere with B-12 absorption or metabolism
  • Use of vitamin supplements
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Human Nutrition Center, University of California Davis

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Vitamin B 12 DeficiencyAchlorhydria

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesAcid-Base ImbalanceMetabolic Diseases

Study Officials

  • Lindsay Allen, PhD

    WHNRC, ARS, University of California Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

US(1)