Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption

This study has been completed.

Study NCT00235573 Information provided by University of Florida

First Received on October 6, 2005. Last Updated on December 15, 2011 History of Changes

Results First Received: September 30, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Bio-availability Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Disorder of Vitamin B12
Intervention:	Dietary Supplement: Vitamin B12

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Gainesville/Alachua county area through newspaper ads, email, and flyers posted on the UF campus. Flyers also were given to individuals or groups. Respondents were interviewed by telephone and asked questions to ascertain if they met inclusion criteria. Individuals meeting criteria were screened for B12 status.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Individuals with a normal general blood chemistry profile, no history of chronic disease and normal CBC and vitamin B12 status were eligible to participate in the study. Those with deficient serum B12 levels were instructed to follow up with their personal physician. Subjects who met all inclusion criteria received the same treatment.

Reporting Groups

	Description
All Study Participants	All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.

Participant Flow: Overall Study

	All Study Participants
STARTED	21 ^[1]
COMPLETED	21
NOT COMPLETED	0

[1]	35 subjects screened; 14 not eligible; 21 started and completed study

Baseline Characteristics

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Reporting Groups

	Description
All Study Participants	All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.

Baseline Measures

	All Study Participants
Number of Participants [units: participants]	21
Age [units: participants]
<=18 years	0
Between 18 and 65 years	21
>=65 years	0
Gender [units: years]
Female	8
Male	13
Region of Enrollment [units: participants]
United States	21

Outcome Measures

1. Primary:

Change in Holo-transcobalamin [ Time Frame: Holo-transcobalamin measured at 24 hours after baseline ]

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2. Secondary:

Total Transcobalamin Measured at Intervals From Baseline to 48 Hours. [ Time Frame: Baseline through 48 hours at intervals of 0, 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6, 7, 8, 9, 10, 11, 11.5, 12.5, 24, 48 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gail Kauwell
Organization: University of Florida
phone: 352-392-1991 ext 227
e-mail: gkauwell@ufl.edu

Publications:

von Castel-Dunwoody KM, Kauwell GP, Shelnutt KP, Vaughn JD, Griffin ER, Maneval DR, Theriaque DW, Bailey LB. Transcobalamin 776C->G polymorphism negatively affects vitamin B-12 metabolism. Am J Clin Nutr. 2005 Jun;81(6):1436-41.

Bor MV, Nexo E, Hvas AM. Holo-transcobalamin concentration and transcobalamin saturation reflect recent vitamin B12 absorption better than does serum vitamin B12. Clin Chem. 2004 Jun;50(6):1043-9. Epub 2004 Mar 25.

Bor MV, Cetin M, Aytac S, Altay C, Nexo E. Nonradioactive Vitamin B12 Absorption Test Evaluated in Controls and in Patients with Inherited Malabsorption of Vitamin B12. Clin Chem. 2005 Sep 15; [Epub ahead of print]

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00235573 History of Changes
Other Study ID Numbers:	433-2005, 7591, M01RR000082
Study First Received:	October 6, 2005
Results First Received:	September 30, 2011
Last Updated:	December 15, 2011
Health Authority:	United States: Institutional Review Board