Gestational diabetes Study ref Design LoE N Intervention/observation/comparison population Results Limitations () Analysis II 504 Analysis of NICHD trial () (included in HTA review) While not reaching statistical significance, Low risk of of 2 and Thrasher Research Fund trial (). there was a trend of a lower rate of bias; see RCTs gestational diabetes in the 4000 IU group Section 2.7 Aim: To assess the safety and health effects of compared to the Control and 2000 IU groups. vitamin D supplementation during pregnancy (5.2 vs 7.3 vs 8.0%) Setting: United States Population: NICHD women with a singleton pregnancy <12–16 wk gestation; Thrasher women at <16 wk gestation Intervention: In the NICHD trial, women were randomized to 400, 2000, or 4000 IU vitamin D3/day, stratified by race. In the Thrasher Research Fund trial, participants were randomized to 2000 or 4000 IU vitamin D3/day. Outcomes: [1] maternal and neonatal 25(OH)D achieved, and [2] maternal comorbidities of pregnancy (COP).
Gestational diabetes Study ref Design LoE N Intervention/observation/comparison population Results Limitations () Analysis of 2 RCTs II 504 Analysis of NICHD trial () (included in HTA review) and Thrasher Research Fund trial (). Aim: To assess the safety and health effects of vitamin D supplementation during pregnancy Setting: United States Population: NICHD women with a singleton pregnancy <12–16 wk gestation; Thrasher women at <16 wk gestation Intervention: In the NICHD trial, women were randomized to 400, 2000, or 4000 IU vitamin D3/day, stratified by race. In the Thrasher Research Fund trial, participants were randomized to 2000 or 4000 IU vitamin D3/day. Outcomes: [1] maternal and neonatal 25(OH)D achieved, and [2] maternal comorbidities of pregnancy (COP). While not reaching statistical significance, there was a trend of a lower rate of gestational diabetes in the 4000 IU group compared to the Control and 2000 IU groups. (5.2 vs 7.3 vs 8.0%) Low risk of bias; see Section 2.7
Vitamin%20D%20evidence%20evaluation%2022May17.docx