The Effect of Vitamin D and Calcium Plus Vitamin D for Leg Cramps in Pregnant Women: A Randomized Clinical (Controlled) Trial

Abstract

Abstract: Introduction: Muscle cramps are painful, local, tangible, and involuntary skeletal muscular contractions that usually affect leg muscles and imbalances between the intake and output of electrolytes and vitamins may lay the ground for muscle cramps. Therefore, aims of this study was to determine the effects of vitamin D and calcium-vitamin D in treating leg cramps as a primary outcome and the effects of vitamin D and calcium-vitamin D in the treatment of sleep disorders, infant anthropometric indicators, Preterm , preterm birth frequency, cesarean delivery frequency as a primary outcome secondary in pregnant women. Methods of the research: This triple blind randomized controlled clinical trial conducted on 126 pregnant women referred to Tabriz health centers in 2013-14. Subjects were allocated into three groups using block randomization. For 60 days, the intervention groups took a 1000 unit vitamin D pill or 300 mg calcium carbonate plus a 1000 unit vitamin D pill, and the control group received a placebo pill every day. The subjects were evaluated with regard to the frequency, length, pain intensity, and time of occurrence of leg cramps during the week before and for 8 weeks after the intervention. Also sleep score was measured before and after the end of intervention and after delivery, during phone call, delivery outcomes including duration of pregnancy, type of delivery and infant anthropometric indicators. ANCOVA test was used for data analysis. Result: Results showed that, by controlling BMI before and during pregnancy, the effects frequency, length and pain intensity leg cramps before the intervention, there was no significant differences in terms of length leg cramps between three groups during 8 weeks (p= 0.730), but there were significant differences between the group receiving vitamin D and the control in terms of leg cramps frequency [adjusted difference = 2.9; confidence interval= 0.8 to 5.0] and pain intensity [adjusted difference = 1.3; confidence interval = 0.3 to 2.2;] (P<0.05) during the first 4 weeks; but there were no significant differences between three groups in terms of leg cramps frequency and pain intensity during the second 4 weeks (P>0.05). Also, by controlling baseline score before the intervention, there was no significant differences in the sleep quality score after the end of intervention between groups (P>0.05). Also there were no significant differences between the group in average neonatal weight (p = 0.579), height (p = 0.841) and head circumference (p = 0.911), duration of pregnancy (p = 0.722), type of delivery (p = 0.436) and gestational age at the time of delivery (p = 0.908). Conclusion: The results show that calcium-vitamin D and vitamin D have no effect on frequency, length, pain intensity of leg cramps, sleep disorders, newborn anthropometric indicators, duration of pregnancy and type of delivery. Future studies should investigate the effects of vitamin D and Cal-D supplements in the form of clinical trials with different doses of these materials and a larger sample. It is suggested that the serum calcium and vitamin D levels and their 24-hour disposal from the body were assessed to obtain results that are more accurate.