No multiple sclerosis relapses during pregnancy if 50,000 IU of Vitamin D weekly – RCT

Created June 2015

Efficacy of high-dose vitamin D3 supplementation in vitamin D deficient pregnant women with multiple sclerosis: Preliminary findings of a randomized-controlled trial.

Iran J Neurol. 2015 Apr 4;14(2):67-73.

Etemadifar M 1, Janghorbani M 2.

1Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

2Department of Epidemiology and Biostatistics, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

Small study with many dropouts – both Vitamin D and placeboWanted > 40 ng, but 50,000 IU weekly was not enoughPDF suggests 10,000 IU daily for ALL women| | | | || --- | --- | --- | --- || Relapses | 50,000 IU | Placebo | Statistically Significant || During pregnancy | 0 % | 56 % | Yes < 0.050 || Up to 6 months after delivery | 0 % | 44 % | No || | || --- | --- || Vitamin D Levels 6 months after | || 50,000 IU | 34 ng || Placebo | 15 ng |Pages listed in BOTH the Vitamin D Life categories Multiple Sclerosis and Pregnancy{category}See alsoOverview MS and vitamin D Overview Pregnancy and vitamin D Ensure a healthy pregnancy and infant with as little as $20 of Vitamin D Update on Treating Multiple Sclerosis with high dose vitamin D - Sept 2013 30 to 50 ng of vitamin D is optimal – Central Europe consensus Sept 2013 Is 50 ng of vitamin D too high, just right, or not enough

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BACKGROUND:

The aim of this preliminary study was to assess the safety and efficacy of high-dose oral vitamin D3 supplementation during pregnancy in women with multiple sclerosis (MS) in Isfahan, Iran.

METHODS:

In a single center open-label randomized, controlled clinical Phase I/II pilot study, 15 pregnant women with confirmed MS with low serum 25-hydroxyvitamin D (25(OH)D) levels were randomly allocated to receive either 50,000 IU/week vitamin D3 or routine care from 12 to 16 weeks of gestation till delivery. The main outcome measures were mean change in serum 25(OH)D levels, expanded disability status scale (EDSS) score, and number of relapse events during pregnancy and within 6 months after delivery.

RESULTS:

Average serum 25(OH)D level at the end of trial in vitamin D3 supplemented group was higher than routine care group (33.7 ng/mL vs. 14.6 ng/ml, P < 0.050). In vitamin D3 group, the mean EDSS did not changed 6 months after delivery (P > 0.050), whereas in routine care group, the mean EDSS increased from 1.3 (0.4) to 1.7 (0.6) (P < 0.070). Women in vitamin D3 group appeared to have fewer relapse events during pregnancy and within 6 months after delivery. No significant adverse events occurred.

CONCLUSION:

Adding high dose vitamin D3 supplementation during pregnancy to routine care of women with MS had significant effect on the serum 25(OH)D levels, EDSS and number of relapse events during pregnancy and within 6 months after delivery.

PMID: 26056550

Clipped from PDF

“A daily supplement of 10,000 IU of vitamin D3 is considered advisable for all adults with normal renal function 22,28 and this dose should be routinely recommended to all women, particularly women with insufficient serum 25(OH)D levels, during pregnancy and lactation.”