Table 3 Individual cases of elevated serum calcium or clinical adverse events among pregnant participants who received 70,000 IU vitamin D3 a
From: Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU) in pregnant and non-pregnant women
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 | |||||