Phase 3
N=13
Vitamin B6 Effects for Women Taking Birth Control Pills
Vitamin B6 Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01128244 ↗Enrolled (actual)
13
Serious AEs
7.7%
Results posted
Dec 2014
Primary outcome: Primary: Total Remethylation of Homocysteine — 6.07; 5.63 micromol/(kg x hr) — p=0.20
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vitamin B6 (Dietary_supplement); Infusion of labeled serine, methionine and leucine (Procedure)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- University of Florida
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Remethylation of Homocysteine |
6.07; 5.63 | 0.20 |
| PRIMARY Flux of Homocysteine Remethylation From Serine-derived Carbon |
6.60; 6.92 | 0.62 |
| PRIMARY Fasting Plasma Pyridoxal Phosphate Concentration |
25.8; 143 | <0.001 sig |
| PRIMARY Fasting Plasma Cystathionine Concentration |
0.14; 0.13 | 0.45 |
| SECONDARY Plasma 3-hydroxykynurenine Concentration |
25.9; 27.3 | <0.05 sig |
Summary
Chronically inadequate B6 nutritional status is associated with aberrant one-carbon (1C) metabolism and health. Plasma pyridoxal phosphate (PLP) >30 nmol/L often has been considered to be the cutoff indicative of nutritional adequacy, with 20-30 nmol/L considered marginal deficiency; however, the current Recommended Dietary Allowance (RDA) value was based on a more conservative cutoff of 20 nmol/L plasma PLP. As shown by in the investigators preliminary data, biochemical perturbations occur when humans have marginal B6 deficiency consistent with plasma PLP of 20-30 nmol/L. A prospective study also showed that plasma PLP 23.3 nmol/L. The mechanism by which low B6 intake is associated with risk of vascular disease is not known. Since B6-deficiency has little tendency to raise fasting plasma total homocysteine (tHcy) but yields an elevated tHcy response following a methionine load, low B6 nutriture may lead to repeated transient mild hyperhomocysteinemia following meal consumption. Several reports of associations between elevated plasma C-reactive protein (CRP) and low B6 status have raised the hypothesis that systemic inflammation is prone to occur during B6 deficiency or contributes to low B6 status. The investigators previously found that healthy humans in low B6 status caused by dietary restriction exhibited normal plasma CRP levels. The investigators also postulate that oxidative stress associated with low B6 status, coupled with impaired glutathione synthesis, contributes to such risk. These questions indicate the need for a more thorough understanding of the metabolic changes occurring in low B6 status from marginal B6 intake and from drug interactions such as in women using oral contraceptives.
Eligibility Criteria
Inclusion Criteria
- healthy female subjects
- normal screening labs
- normal body weight
- nonpregnant
- Plasma PLP<30nmol/L
Exclusion Criteria
- history of gastrointestinal surgery
- chronic disease
- vitamin supplementation
- high protein diet
- progesterone
- no smoking
- chronic drug use
- alcoholism
- no vitamin supplementation
Data sourced from ClinicalTrials.gov (NCT01128244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.