Table 3

Individual cases of elevated serum calcium or clinical adverse events among pregnant participants who received 70,000 IU vitamin D3a
Event Biochemistryb Action Outcome
ID Description Time of onset Timing Albumin –adjusted serum [Ca] (mmol/L) Urine Ca:Cr (mmol/ mmol) [25(OH)D] (nmol/L)
1 Neonatal: Neonatal death, secondary to respiratory failure, and pulmonary hemorrhage. Delivery at 36 weeks gestation; day 42 of follow-up. Baseline 2.43 0.05 95 Admitted to a neonatal intensive care unit. Newborn died in hospital on postnatal day 3. No maternal complications.
Event 2.38 0.74 71
Post-event 2.46 0.16 80
Range 2.38 to 2.48 0.05 to 0.74 71 to 116
Cord blood 2.69 72
2 Pregnancy: Referral to hospital due to severe headache and vomiting. 32 weeks gestation; day 17 of follow-up. Baseline 2.25 0.22 46 Admitted to tertiary-care hospital. Discharged on day 2 of admission; no further complications. Delivered term infant; no complications.
Event 2.26 0.74 85
Post-event 2.29 1.04 75
Range 2.24 to 2.37 0.22 to 1.04 46 to 85
Cord blood 2.51 49
3 Pregnancy: Physician suspected irregular fetal heart rate; asymptomatic. 34 weeks gestation; day 28 of follow-up. Baseline 2.30 0.39 54 Assessment at tertiary-care hospital. Normal biophysical profile; normal pregnancy. No intervention required.
Event 2.45 0.18 54
Post-event 2.50 1.48; repeat was 0.66 53
Pregnancy: Isolated albumin-adjusted serum [Ca] of 2.61 mmol/L. 1 week post-partum; day 70 of follow-up Event 2.61 0.6 47 Repeat biochemistry was normal. No intervention required Asymptomatic. No maternal or newborn complications (delivery occurred at 39 weeks gestation).
Post-event 2.52 30
Range 2.3 to 2.61 0.14 to 1.74 47 to 70
Cord blood 2.61 30
4 Pregnancy: Intrauterine fetal death, associated with placental abruption, hypertension and possible abdominal trauma. 35 weeks, 5 days gestational age. Baseline 2.38 0.02 21 Fetus delivered by cesarean section. Intrauterine fetal death, secondary to placental abruption. No further maternal complications
Event 2.38 0.05 45
Post-event 2.46 0.05 46
Range 2.31 to 2.46 0.02 to 0.57 21 to 52
Cord blood 2.28 29

a. Table includes participants with at least one serum albumin-adjusted calcium concentration measurement greater than 2.60 mmol/L or a serious clinical adverse event at any time during follow-up, among participants in the single-dose only group.

b. All values refer to serum concentrations in maternal venous blood except for the row labeled “cord blood”. “Range” refers to the participant’s range of values during the entire follow-up period.

Roth et al.

Roth et al. Nutrition Journal 2012 11:114   doi:10.1186/1475-2891-11-114

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