Trial Outcomes & Findings for Vitamin B6 Effects for Women Taking Birth Control Pills (NCT NCT01128244)
NCT ID: NCT01128244
Last Updated: 2017-02-07
Results Overview
Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of total remethylation of homocysteine before and after vitamin B6 supplementation.
COMPLETED
PHASE2/PHASE3
13 participants
Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days
2017-02-07
Participant Flow
Participant milestones
| Measure |
Vitamin B6 Effects in OC Users
Subjects will be given an infusion of the amino acids serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
Vitamin B6: Subjects will receive vitamin B6 supplementation.
Infusion of the amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Vitamin B6 Effects in OC Users
Subjects will be given an infusion of the amino acids serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
Vitamin B6: Subjects will receive vitamin B6 supplementation.
Infusion of the amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Scheduling conflict
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2
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Baseline Characteristics
Vitamin B6 Effects for Women Taking Birth Control Pills
Baseline characteristics by cohort
| Measure |
Vitamin B6 Effects in OC Users
n=13 Participants
Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
Vitamin B6: Subjects will receive vitamin B6 supplementation.
Infusion of amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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13 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
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Gender
Female
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13 Participants
n=99 Participants
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Gender
Male
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Black or African American
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2 Participants
n=99 Participants
|
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Race (NIH/OMB)
White
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11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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13 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 daysPopulation: Women using oral contraceptives exhibiting low vitamin B6 status evaluated at baseline and after vitamin B6 supplementation.
Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of total remethylation of homocysteine before and after vitamin B6 supplementation.
Outcome measures
| Measure |
Total Homocysteine Remethylation Flux
n=10 Participants
All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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Total Remethylation of Homocysteine
After 28-days of vitamin supplementation
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5.63 micromol/(kg x hr)
Standard Deviation 1.1
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Total Remethylation of Homocysteine
Baseline prior to vitamin supplementation
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6.07 micromol/(kg x hr)
Standard Deviation 1.1
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PRIMARY outcome
Timeframe: Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 daysPopulation: Women using oral contraceptives and exhibiting low vitamin B6 status.
Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of homocysteine remethylation from serine-derived carbon before and after vitamin B6 supplementation. These flux values may be slightly higher than flux of total homocysteine remethylation in Outcome Measure 1 because of the small contribution of methionine salvage to the flux measured in Outcome Measure 2.
Outcome measures
| Measure |
Total Homocysteine Remethylation Flux
n=10 Participants
All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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Flux of Homocysteine Remethylation From Serine-derived Carbon
Baseline prior to vitamin supplementation
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6.60 micromol/(kg x hr)
Standard Deviation 1.9
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Flux of Homocysteine Remethylation From Serine-derived Carbon
After 28-days of vitamin supplementation
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6.92 micromol/(kg x hr)
Standard Deviation 2.2
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PRIMARY outcome
Timeframe: Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.Population: Women using oral contraceptives and exhibiting low vitamin B6 status.
For all subjects, the concentration of plasma pyridoxal phosphate in fasting blood samples taken before and after the supplementation period will provide a direct measure of vitamin B6 nutritional status.
Outcome measures
| Measure |
Total Homocysteine Remethylation Flux
n=10 Participants
All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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Fasting Plasma Pyridoxal Phosphate Concentration
After 28-days of vitamin supplementation
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143 nmol/L
Standard Deviation 58
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Fasting Plasma Pyridoxal Phosphate Concentration
Baseline prior to vitamin supplementation
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25.8 nmol/L
Standard Deviation 3.6
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PRIMARY outcome
Timeframe: Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.Population: Women using oral contraceptives and exhibiting low vitamin B6 status.
For all subjects, the concentration of plasma cystathionine in fasting blood samples taken before and after the supplementation period will provide a functional measure of vitamin B6 nutritional status.
Outcome measures
| Measure |
Total Homocysteine Remethylation Flux
n=10 Participants
All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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Fasting Plasma Cystathionine Concentration
Baseline prior to vitamin supplementation
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0.14 micromol/L
Standard Deviation 0.06
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Fasting Plasma Cystathionine Concentration
After 28-days of vitamin supplementation
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0.13 micromol/L
Standard Deviation 0.06
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SECONDARY outcome
Timeframe: April, 2010 - June, 2014Population: Women using oral contraceptives and exhibiting low vitamin B6 status.
For all subjects, analysis of blood samples before and after vitamin B6 supplementation will allow evaluation of discriminating biomarkers using targeted metabolite profile analysis of one-carbon metabolism and tryptophan catabolism constituents. Also, we will conduct exploratory evaluation and potential identification of new biomarkers using metabolomics analysis on subjects before and after vitamin B6 supplementation.
Outcome measures
| Measure |
Total Homocysteine Remethylation Flux
n=10 Participants
All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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Plasma 3-hydroxykynurenine Concentration
Baseline prior to vitamin supplementation
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25.9 microl/L
Standard Deviation 14.0
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Plasma 3-hydroxykynurenine Concentration
After 28-days of vitamin supplementation
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27.3 microl/L
Standard Deviation 14.0
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Adverse Events
Vitamin B6 Effects in OC Users
Serious adverse events
| Measure |
Vitamin B6 Effects in OC Users
n=13 participants at risk
Subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
Vitamin B6: Subjects will receive vitamin B6 supplementation.
Infusion of amino acids, serine, and methionine: Subjects will be given an infusion of the amino acids, serine, and methionine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
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|---|---|
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General disorders
Vasovagal reaction
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7.7%
1/13 • Number of events 1
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place