Effectiveness of Prenatal Vitamin D Deficiency Screening and Treatment Program: A Stratified Randomized Field Trial

Context: Despite evidence on the association between hypovitaminosis D and adverse pregnancy outcomes and the positive impact of vitamin D supplementation, no evidence exists supporting a universal screening program in pregnancy as part of routine prenatal care. Objective: We sought to determine the effectiveness of a prenatal screening program on optimizing 25-hydroxyvitamin D [25(OH)D] levels and preventing pregnancy complications. Also, to identify a safe regimen, we compared several regimens in a subgroup of vitamin D-deficient pregnant women. Design: Two cities of Masjed-Soleyman and Shushtar from Khuzestan province, Iran, were selected as the screening and nonscreening arms, respectively. Within the screening arm, a randomized controlled trial was conducted on 800 pregnant women. Setting: Health centers of Masjed-Soleyman and Shushtar cities. Patients or Participants: Pregnant women aged 18 to 40 years. Intervention: Women with moderate [25(OH)D, 10 to 20 ng/mL] and severe [25(OH)D, <10 ng/mL] deficiency were randomly divided into four subgroups and received vitamin D-3 (D3) until delivery. Main Outcome Measure: Maternal concentration of 25(OH)D at delivery and rate of pregnancy complications Results: After supplementation, only 2% of the women in the nonscreening site met the sufficiency level (>20 ng/mL) vs 53% of the women in the screening site. Adverse pregnancy outcomes, including preeclampsia, gestational diabetes mellitus, and preterm delivery, were decreased by 60%, 50%, and 40%, respectively, in the screening site. A D3 injection in addition to monthly 50,000 IU maintenance therapy contributed the most to achievement of sufficient levels at delivery. Conclusions: A prenatal vitamin D screening and treatment program is an effective approach in detecting deficient women, improving 25(OH)D levels, and decreasing pregnancy adverse outcomes.