Pharmacokinetics of high-dose weekly oral vitamin D3 supplementation during the third trimester of pregnancy in Dhaka, Bangladesh

Daniel E. Roth, Abdullah Al Mahmud, Rubhana Raqib, Evana Akhtar, Robert E Black, Abdullah Baqui

Research output: Contribution to journalArticle

Abstract

A pharmacokinetic study was conducted to assess the biochemical dose-response and tolerability of high-dose prenatal vitamin D3 supplementation in Dhaka, Bangladesh (23°N). Pregnant women at 27-30 weeks gestation (n = 28) were randomized to 70,000 IU once + 35,000 IU/week vitamin D3 (group PH: pregnant, higher dose) or 14,000 IU/week vitamin D3 (PL: pregnant, lower dose) until delivery. A group of non-pregnant women (n = 16) was similarly administered 70,000 IU once + 35,000 IU/week for 10 weeks (NH: non-pregnant, higher-dose). Rise (Δ) in serum 25-hydroxyvitamin D concentration ([25(OH)D]) above baseline was the primary pharmacokinetic outcome. Baseline mean [25(OH)D] were similar in PH and PL (35 nmol/L vs. 31 nmol/L, p = 0.34). A dose-response effect was observed: Δ[25(OH)D] at modeled steady-state was 19 nmol/L (95% CI, 1 to 37) higher in PH vs. PL (p = 0.044). Δ[25(OH)D] at modeled steady-state was lower in PH versus NH but the difference was not significant (-15 nmol/L, 95% CI -34 to 5; p = 0.13). In PH, 100% attained [25(OH)D] ≥ 50 nmol/L and 90% attained [25(OH)D] ≥ 80 nmol/L; in PL, 89% attained [25(OH)D] ≥ 50 nmol/L but 56% attained [25(OH)D] ≥ 80 nmol/L. Cord [25(OH)D] (n = 23) was slightly higher in PH versus PL (117 nmol/L vs. 98 nmol/L; p = 0.07). Vitamin D3 was well tolerated; there were no supplement-related serious adverse clinical events or hypercalcemia. In summary, a regimen of an initial dose of 70,000 IU and 35,000 IU/week vitamin D3 in the third trimester of pregnancy was non-hypercalcemic and attained [25(OH)D] ≥ 80 nmol/L in virtually all mothers and newborns. Further research is required to establish the safety of high-dose vitamin D3 in pregnancy and to determine if supplement-induced [25(OH)D] elevations lead to maternal-infant health benefits.

Original languageEnglish (US)
Pages (from-to)788-810
Number of pages23
JournalNutrients
Volume5
Issue number3
DOIs
StatePublished - Mar 12 2013

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Bangladesh
cholecalciferol
Cholecalciferol
Third Pregnancy Trimester
pharmacokinetics
mouth
Pharmacokinetics
pregnancy
dosage
dose response
hypercalcemia
Pregnancy
Hypercalcemia
Insurance Benefits
pregnant women
Pregnant Women
neonates
Safety
Serum
Research

Keywords

  • Bangladesh
  • Hypercalcemia
  • Pharmacokinetics
  • Pregnancy
  • Vitamin D

ASJC Scopus subject areas

  • Food Science

Cite this

Pharmacokinetics of high-dose weekly oral vitamin D3 supplementation during the third trimester of pregnancy in Dhaka, Bangladesh. / Roth, Daniel E.; Al Mahmud, Abdullah; Raqib, Rubhana; Akhtar, Evana; Black, Robert E; Baqui, Abdullah.

In: Nutrients, Vol. 5, No. 3, 12.03.2013, p. 788-810.

Research output: Contribution to journalArticle

Roth, Daniel E. ; Al Mahmud, Abdullah ; Raqib, Rubhana ; Akhtar, Evana ; Black, Robert E ; Baqui, Abdullah. / Pharmacokinetics of high-dose weekly oral vitamin D3 supplementation during the third trimester of pregnancy in Dhaka, Bangladesh. In: Nutrients. 2013 ; Vol. 5, No. 3. pp. 788-810.
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