Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU) in pregnant and non-pregnant women

Roth, Daniel; Mahmud, Abdullah Al; Raqib, Rubhana; Black, Robert E.; Baqui, Abdullah H

doi:10.1186/1475-2891-11-114

Cited by 22 publications

(25 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The response to the higher-dose supplement regimen was also assessed in a cohort of non-pregnant participants that served as a separate comparison group. The present study builds on previously reported observations of single-dose vitamin D3 pharmacokinetics in the same setting [13]. …”

Section: Introductionmentioning

confidence: 58%

“…NH was studied before enrolment of PH, to establish safety of the high-dose regimen in non-pregnant women prior to its use in pregnant women. As an additional safety measure, the response to a single initial dose vitamin D3 (70,000 IU) was observed in a separate cohort, prior to the initiation of enrollment of cohorts of participants who received weekly doses [13]. A preceding report of single-dose vitamin D3 pharmacokinetics included data from participants in weekly-dose groups PH and NH, but only from days 0 to 7 ( i.e.…”

Section: Methodsmentioning

confidence: 99%

“…A preceding report of single-dose vitamin D3 pharmacokinetics included data from participants in weekly-dose groups PH and NH, but only from days 0 to 7 ( i.e. , preceding the administration of a second vitamin D dose) [13]. Women who received only the single 70,000 IU dose are not included in any of the present analyses.…”

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Pharmacokinetics of High-Dose Weekly Oral Vitamin D3 Supplementation during the Third Trimester of Pregnancy in Dhaka, Bangladesh

et al. 2013

Self Cite

View full text Add to dashboard Cite

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 (∆) 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: ∆[25(OH)D] at modeled steady-state was 19 nmol/L (95% CI, 1 to 37) higher in PH vs. PL (p = 0.044). ∆[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.

show abstract

Section: Introductionmentioning

confidence: 58%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetics of High-Dose Weekly Oral Vitamin D3 Supplementation during the Third Trimester of Pregnancy in Dhaka, Bangladesh

et al. 2013

Self Cite

View full text Add to dashboard Cite

show abstract

“…Plasma folate concentrations showed no statistically significant changes [221,222], but conflicting change directions were seen in the mean values, depending on the dose [222]. Similarly, vitamin D3 showed conflicting change directions in exposure parameters, which were statistically non-significant [223,224]. …”

Section: Resultsmentioning

confidence: 99%

Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review

et al. 2016

View full text Add to dashboard Cite

BackgroundWomen are commonly prescribed a variety of medications during pregnancy. As most organ systems are affected by the substantial anatomical and physiological changes that occur during pregnancy, it is expected that pharmacokinetics (PK) (absorption, distribution, metabolism, and excretion of drugs) would also be affected in ways that may necessitate changes in dosing schedules. The objective of this study was to systematically identify existing clinically relevant evidence on PK changes during pregnancy.Methods and FindingsSystematic searches were conducted in MEDLINE (Ovid), Embase (Ovid), Cochrane Central Register of Controlled Trials (Ovid), and Web of Science (Thomson Reuters), from database inception to August 31, 2015. An update of the search from September 1, 2015, to May 20, 2016, was performed, and relevant data were added to the present review. No language or date restrictions were applied. All publications of clinical PK studies involving a group of pregnant women with a comparison to nonpregnant participants or nonpregnant population data were eligible to be included in this review. A total of 198 studies involving 121 different medications fulfilled the inclusion criteria. In these studies, commonly investigated drug classes included antiretrovirals (54 studies), antiepileptic drugs (27 studies), antibiotics (23 studies), antimalarial drugs (22 studies), and cardiovascular drugs (17 studies). Overall, pregnancy-associated changes in PK parameters were often observed as consistent findings among many studies, particularly enhanced drug elimination and decreased exposure to total drugs (bound and unbound to plasma proteins) at a given dose. However, associated alterations in clinical responses and outcomes, or lack thereof, remain largely unknown.ConclusionThis systematic review of pregnancy-associated PK changes identifies a significant gap between the accumulating knowledge of PK changes in pregnant women and our understanding of their clinical impact for both mother and fetus. It is essential for clinicians to be aware of these unique pregnancy-related changes in PK, and to critically examine their clinical implications.

show abstract

“…Likewise, we did not document any notable pregnancy-related hypersensitivity to a vitamin D dose of 70,000 IU in terms of its effects on calcium homeostasis. However, the unpredictability of the 25(OH)D response at the individual level, previous reports of adverse effects of large single doses [23], and the theoretical disadvantages of excessive fluctuations in vitamin D status [29] suggest that the use of large single or infrequent intermittent doses of vitamin D3 may be physiologically disadvantageous despite its practical appeal. Therefore, these data principally support the further investigation of single doses equal to or less than 70,000 IU in the context of intermittent (e.g., weekly or biweekly) antenatal dosing regimens.…”

Section: Discussionmentioning

confidence: 95%

- Consumption of Fructose and High Fructose Corn Syrup Increase Postprandial Triglycerides, LDL-Cholesterol, and Apolipoprotein-B in Young Men and Women

2015

Nutritional Biochemistry

View full text Add to dashboard Cite

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.

show abstract

Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU) in pregnant and non-pregnant women

Cited by 22 publications

References 24 publications

Pharmacokinetics of High-Dose Weekly Oral Vitamin D3 Supplementation during the Third Trimester of Pregnancy in Dhaka, Bangladesh

Pharmacokinetics of High-Dose Weekly Oral Vitamin D3 Supplementation during the Third Trimester of Pregnancy in Dhaka, Bangladesh

Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review

- Consumption of Fructose and High Fructose Corn Syrup Increase Postprandial Triglycerides, LDL-Cholesterol, and Apolipoprotein-B in Young Men and Women

Contact Info

Product

Resources

About