4000 IU Vitamin D Safe and Effective For Healthy Pregnant Women – RCT June 2011

Vitamin D Supplementation during Pregnancy: Double Blind, Randomized Clinical Trial of Safety and Effectiveness

Medical News today
Use of vitamin D supplements during pregnancy has long been a matter of concern but now researchers writing in the Journal of Bone and Mineral Research report that even a high supplementation amount in healthy pregnant women was safe and effective in raising circulating vitamin D to a level thought by some to be optimal. The study also found no adverse effects of vitamin D supplementation, even at the highest amount, in women or their newborns.

The research team, led by Dr. Bruce Hollis from the Medical University of South Carolina in Charleston, used a randomized controlled trial with healthy expectant mothers to discover how varying dosages of daily supplements could safely sustain a circulating vitamin D level of at least 32 nanograms per milliliter.

"Vitamin D supplementation during pregnancy remains controversial largely due to severe misconceptions about the potential harm it may cause to the fetus," said Dr Hollis. "Surprisingly the scientific debate has made little progress since Dr. Gilbert Forbes made a recommendation of 200 IU (international units) per day in 1963, which was based on a hunch."

While the threat of vitamin D during pregnancy has remained little known, it has been established that the vitamin plays a role in homeostasis, the body's internal regulation, during pregnancy and that a deficiency can effect immune, pancreatic and cardiovascular systems.

Dr Hollis' team monitored the pregnancies of 350 women, from a variety of ethnic and socio-economic backgrounds, who were all between 12 and 16 weeks into gestation. The women were randomly assigned to one of three groups.

• One group received 400 IU of vitamin D per day, the
• second group received 2,000 IU per day and the
• third received 4,000 IU daily.

The team found that women who received the highest level of supplementation (4,000 IU per day) were more likely to achieve and sustain the desired level of circulating levels of vitamin D throughout their pregnancy. Moreover, the researchers found that pregnant women who received lower levels of vitamin D supplementation did not attain the threshold circulating level of the vitamin.

"In our study subjects, a daily dosage of up to 4,000 IU of vitamin D was required to sustain normal metabolism in pregnant women," concluded Dr Hollis. "Furthermore, following decades of speculation into its safety our research has demonstrated vitamin D supplementation to be both safe and effective."

Study

Hollis. B, Johnson. D, Hulsey. T, Ebeling. M, Wagner. L, "Vitamin D Supplementation during Pregnancy: Double Blind, Randomized Clinical Trial of Safety and Effectiveness", Journal of Bone and Mineral Research, Wiley-Blackwell, June 2011: DOI: 10.1002/jbmr.463
Abstract

Background: The need, safety and effectiveness of vitamin D supplementation during pregnancy remain controversial.

Design: In this randomized controlled trial, women with a singleton pregnancy at 12?16 weeks' gestation received 400, 2000 or 4000 IU vitamin D3/day until delivery. The primary outcome was maternal/neonatal circulating 25(OH)D at delivery, with secondary outcomes 25(OH)D ?80 nmol/L achieved and 25(OH)D concentration required to achieve maximal 1,25(OH)2D production.

Results: Of the 494 women enrolled, 350 women continued until delivery: Mean 25(OH)D by group at delivery and 1?month before delivery were significantly different (p<0.0001), and percent who achieved sufficiency was significantly different by group, greatest in 4000 IU group (p<0.0001). The relative risk (RR) for achieving ?80 nmol/L within one month of delivery was significantly different between 2000 vs. 400 IU (RR 1.52 [CI 1.24?1.86]); 4000 vs. 400 (RR 1.60 [CI 1.32?1.95]), but not between 4000 vs. 2000 (RR 1.06 [CI 0.93?1.19]). Circulating 25(OH)D had a direct influence on circulating 1,25(OH)2D concentrations throughout pregnancy (p<0.0001) with maximal production of 1,25(OH)2D in all strata in the 4000 IU group. There were no differences between groups on any safety measure. Not a single adverse event was attributed to vitamin D supplementation or circulating 25(OH)D levels.

Conclusions: Vitamin D supplementation of 4,000 IU/day for pregnant women was safe and most effective in achieving sufficiency in all women and their neonates regardless of race while the current estimated average requirement was comparatively ineffective at achieving adequate circulating
25(OH)D, especially in African Americans.

Conclusions in paper

In summary, starting at 12 to 16 weeks of gestation, vitamin D supplementation with 4,000 IU/day was most effective in achieving vitamin D sufficiency throughout pregnancy, one month prior to delivery and at delivery in a diverse group of women and their neonates without increased risk of toxicity. These findings suggest that the current vitamin D EAR and RDA for pregnancy women issued in 2010 by the Institute of Medicine (62) should be raised to 4,000 IU vitamin D per day so that all women regardless of race attain optimal nutritional and hormonal vitamin D status throughout pregnancy.

 Download the PDF from Vitamin D Life

Example Chart: 4000 IU of vitamin D

• half a week longer pregnancy (more full term)
• 2X fewer C-Sections without labor
• 15% more vaginal births

- - - - - - Paper finally published in Oct 2011 - - - - - - - -

Vitamin D supplementation during pregnancy: Double-blind, randomized clinical trial of safety and effectiveness.

J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463.
Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL.
Division of Neonatology and Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC, USA. hollisb at musc.edu.

The need, safety, and effectiveness of vitamin D supplementation during pregnancy remain controversial. In this randomized, controlled trial, women with a singleton pregnancy at 12 to 16 weeks' gestation received 400, 2000, or 4000?IU of vitamin D(3) per day until delivery. The primary outcome was maternal/neonatal circulating 25-hydroxyvitamin D [25(OH)D] concentration at delivery, with secondary outcomes of a 25(OH)D concentration of 80?nmol/L or greater achieved and the 25(OH)D concentration required to achieve maximal 1,25-dihydroxyvitamin D(3) [1,25(OH)(2) D(3) ] production.

Of the 494 women enrolled, 350 women continued until delivery: Mean 25(OH)D concentrations by group at delivery and 1 month before delivery were significantly different (p?<?0.0001), and the percent who achieved sufficiency was significantly different by group, greatest in 4000-IU group (p?<?0.0001).

The relative risk (RR) for achieving a concentration of 80?nmol/L or greater within 1 month of delivery was significantly different between the 2000- and the 400-IU groups (RR?=?1.52, 95% CI 1.24-1.86), the 4000- and the 400-IU groups (RR?=?1.60, 95% CI 1.32-1.95) but not between the 4000- and. 2000-IU groups (RR?=?1.06, 95% CI 0.93-1.19).

Circulating 25(OH)D had a direct influence on circulating 1,25(OH)(2) D(3) concentrations throughout pregnancy (p?<?0.0001), with maximal production of 1,25(OH)(2) D(3) in all strata in the 4000-IU group. There were no differences between groups on any safety measure.

Not a single adverse event was attributed to vitamin D supplementation or circulating 25(OH)D levels. It is concluded that vitamin D supplementation of 4000?IU/d for pregnant women is safe and most effective in achieving sufficiency in all women and their neonates regardless of race, whereas the current estimated average requirement is comparatively ineffective at achieving adequate circulating 25(OH)D concentrations, especially in African Americans. © 2011 American Society for Bone and Mineral Research.
Copyright © 2011 American Society for Bone and Mineral Research.
PMID: 21706518

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Target was 80 nmol = 32 nanograms

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See also Vitamin D Life

• Pregnancies need a lot of vitamin D, even before conception - Hollis Dec 2018
• Overview Pregnancy and Vitamin D
• Pregnancy and Vitamin D 751 items
• Breastfeeding mother getting 6400 IU of Vitamin D is similar to infant getting 400 IU – RCT Sept 2015
• Unplanned cesarean 2X more likely if vitamin D deficient – April 2012
• Vitamin D is being used to prevent premature births – Baggerly interview – Dec 2015
• Preterm birth rate reduced 57 percent by Vitamin D – Nov 2015 - re-analysis of the data
• Seniors need at least 4,000 IU vitamin D, no test needed – Consensus Jan 2014