Trial Outcomes & Findings for Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption (NCT NCT00235573)
NCT ID: NCT00235573
Last Updated: 2011-12-22
Results Overview
Holo-TC is a vitamin B12 carrier protein. Only vitamin B12 bound to holo-TC can be taken up by cells. Changes in holo-TC after an oral dose of vitamin B12 may provide a clinical test to assess vitamin B12 absorption. The change in holo-transcobalamin (holo-TC) from baseline was measured at timed intervals in response to supplemental vitamin B12 and compared to baseline. The purpose was to ascertain the time point at which holo-TC reaches the maximum concentration in the blood following a dose of vitamin B12 in subjects without defects in vitamin B12 absorption.
COMPLETED
NA
21 participants
Holo-transcobalamin measured at 24 hours after baseline
2011-12-22
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption
Baseline characteristics by cohort
| Measure |
All Study Participants
n=21 Participants
All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Holo-transcobalamin measured at 24 hours after baselinePopulation: The number of participants for analysis was per protocol.
Holo-TC is a vitamin B12 carrier protein. Only vitamin B12 bound to holo-TC can be taken up by cells. Changes in holo-TC after an oral dose of vitamin B12 may provide a clinical test to assess vitamin B12 absorption. The change in holo-transcobalamin (holo-TC) from baseline was measured at timed intervals in response to supplemental vitamin B12 and compared to baseline. The purpose was to ascertain the time point at which holo-TC reaches the maximum concentration in the blood following a dose of vitamin B12 in subjects without defects in vitamin B12 absorption.
Outcome measures
| Measure |
Vitamin B12 Group
n=21 Participants
All subjects received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
|
|---|---|
|
Change in Holo-transcobalamin
|
124 pmol/L
Standard Deviation 46
|
SECONDARY outcome
Timeframe: 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, 48Outcome measures
Outcome data not reported
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place