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Phase 3 N=13 Treatment

Vitamin B6 Effects for Women Taking Birth Control Pills

Vitamin B6 Deficiency

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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