Vitamin B6 Effects for Women Taking Birth Control Pills

Completed · Phase 2/Phase 3

Conditions studied: Vitamin B6 Deficiency

In brief

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 is associated with 1.8-times higher risk of recurrent venous thromboembolism than those with 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.

Key facts

Study ID

NCT01128244

Run by

University of Florida

People needed

13

Starts

2010-04-01

Expected to finish

2014-06-01

Last updated by the study team

2017-02-07

Who can join

Age: 20 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• healthy female subjects
• normal screening labs
• normal body weight
• nonpregnant
• Plasma PLP<30nmol/L

You may not qualify if…

• history of gastrointestinal surgery
• chronic disease
• vitamin supplementation
• high protein diet
• progesterone
• no smoking
• chronic drug use
• alcoholism
• no vitamin supplementation

Where it is running

• University of Florida Clinical Research Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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