Health Characteristics and Outcomes of Two Randomized Vitamin D Supplementation Trials during Pregnancy: A Combined Analysis.
J Steroid Biochem Mol Biol. 2013 Jan 10. pii: S0960-0760(13)00006-X. doi: 10.1016/j.jsbmb.2013.01.002.
Wagner CL, McNeil RB, Johnson DD, Hulsey TC, Ebeling M, Robinson C, Hamilton SA, Hollis BW.
Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC; Eau Claire Cooperative Health Centers, Columbia, SC. Electronic address: wagnercl at musc.edu.
OBJECTIVE: To assess the safety and health effects of vitamin D supplementation during pregnancy. Methods and Design: Datasets from two randomized clinical trials were first analyzed separately then combined for this analysis using a common data dictionary. In the NICHD trial, women were randomized to 400, 2000, or 4000 IU vitamin D(3)/day, stratified by race. In the Thrasher Research Fund trial, participants were randomized to 2000 or 4000 IU vitamin D(3)/day. Study drugs were from the same manufacturing lot for both trials. Identical questionnaires were given for comparable sociodemographics & clinical characteristics. Outcome measures were:  maternal and neonatal 25(OH)D achieved, and  maternal comorbidities of pregnancy (COP). SAS 9.3 was used for all analyses.
RESULTS: In the combined cohort, there were 110 controls, 201 in the 2000 IU group, and 193 in the 4000 IU group. No differences between groups in baseline 25(OH)D were found; however, delivery and cord blood values were greater in the 4000 IU group (p<0.0001), an effect that persisted even after controlling for race and study. A greater percent were vitamin D replete in the 4000 IU group (p<0.0001). There was a trend where the 4000 IU group had decreased rates of comorbidities of pregnancy. There was a strong association between COP and final maternal 25(OH)D; an effect that persisted even after controlling for race and study (p=0.006).
CONCLUSIONS: Supplementation with 4000 IU/day was associated with lower risk of hypovitaminosis D than Control and 2000 IU groups. While not statistically significant, there was a trend toward lower rates of COP as supplementation dose increased. Maternal delivery 25(OH)D was inversely associated with any comorbidity of pregnancy, with fewer events as 25(OH)D increased. Future studies are needed to confirm these findings and determine the mechanisms of action of such effects.
Copyright © 2013. Published by Elsevier Ltd.
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Healthy pregnancies need lots of vitamin D has the following summaryProblem
Reduces Evidence 0. Chance of not conceiving 3.4 times Observe 1. Miscarriage 2.5 times Observe 2. Pre-eclampsia 3.6 times RCT 3. Gestational Diabetes 3 times RCT 4. Good 2nd trimester sleep quality 3.5 times Observe 5. Premature birth 2 times RCT 6. C-section - unplanned 1.6 times Observe Stillbirth - OMEGA-3 4 times RCT - Omega-3 7. Depression AFTER pregnancy 1.4 times RCT 8. Small for Gestational Age 1.6 times meta-analysis 9. Infant height, weight, head size
within normal limits
RCT 10. Childhood Wheezing 1.3 times RCT 11. Additional child is Autistic 4 times Intervention 12.Young adult Multiple Sclerosis 1.9 times Observe 13. Preeclampsia in young adult 3.5 times RCT 14. Good motor skills @ age 3 1.4 times Observe 15. Childhood Mite allergy 5 times RCT 16. Childhood Respiratory Tract visits 2.5 times RCT
RCT = Randomized Controlled Trial