title: Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU) in pregnant and non-pregnant women.
abstract: BACKGROUND
  Improvements in antenatal vitamin D status may have maternal-infant health benefits. To inform the design of prenatal vitamin D3 trials, we conducted a pharmacokinetic study of single-dose vitamin D3 supplementation in women of reproductive age.
  
  
  METHODS
  A single oral vitamin D3 dose (70,000 IU) was administered to 34 non-pregnant and 27 pregnant women (27 to 30 weeks gestation) enrolled in Dhaka, Bangladesh (23°N). The primary pharmacokinetic outcome measure was the change in serum 25-hydroxyvitamin D concentration over time, estimated using model-independent pharmacokinetic parameters.
  
  
  RESULTS
  Baseline mean serum 25-hydroxyvitamin D concentration was 54 nmol/L (95% CI 47, 62) in non-pregnant participants and 39 nmol/L (95% CI 34, 45) in pregnant women. Mean peak rise in serum 25-hydroxyvitamin D concentration above baseline was similar in non-pregnant and pregnant women (28 nmol/L and 32 nmol/L, respectively). However, the rate of rise was slightly slower in pregnant women (i.e., lower 25-hydroxyvitamin D on day 2 and higher 25-hydroxyvitamin D on day 21 versus non-pregnant participants). Overall, average 25-hydroxyvitamin D concentration was 19 nmol/L above baseline during the first month. Supplementation did not induce hypercalcemia, and there were no supplement-related adverse events.
  
  
  CONCLUSIONS
  The response to a single 70,000 IU dose of vitamin D3 was similar in pregnant and non-pregnant women in Dhaka and consistent with previous studies in non-pregnant adults. These preliminary data support the further investigation of antenatal vitamin D3 regimens involving doses of ≤70,000 IU in regions where maternal-infant vitamin D deficiency is common.
authors.affiliation: Department of International Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA. daniel.roth@sickkids.ca
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Roth
authors.forename: Abdullah
authors.initials: A
authors.lastname: Al Mahmud
authors.forename: Rubhana
authors.initials: R
authors.lastname: Raqib
authors.forename: Robert E
authors.initials: RE
authors.lastname: Black
authors.forename: Abdullah H
authors.initials: AH
authors.lastname: Baqui
mesh_terms: D000293:Adolescent; D000328:Adult; D001459:Bangladesh; D002118:Calcium / Q000652:urine; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics*; D003404:Creatinine / Q000652:urine; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006934:Hypercalcemia / Q000139:chemically induced; D011247:Pregnancy; D012709:Serum Albumin / Q000032:analysis / Q000378:metabolism; D013048:Specimen Handling; D016896:Treatment Outcome; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy; D055815:Young Adult
chemical_list: D012709:Serum Albumin; D002762:Cholecalciferol; D003404:Creatinine; D002118:Calcium