Table 3.
Maternal and Infant Biochemical Measurements at Visits 1, 4, and 7 by 400 and 6,400 IU Groups in Exclusively Formula-Feeding Mother/Infant Dyads (n = 66)
| 400 IU (n = 34) | 6,400 IU (n = 32) | p-Value* | |
|---|---|---|---|
| Maternal | |||
| 25(OH)D (nmol/L), mean ± SD | |||
| Visit 1 (n = 66) | 68.6 ± 31.1 | 56.6 ± 24.2 | 0.09 |
| Visit 4 (n = 56) | 72.6 ± 37.0 | 96.3 ± 55.5 | 0.07 |
| Visit 7 (n = 50) | 65.2 ± 28.2 | 109.2 ± 71.6 | 0.006 |
| D3 (nmol/L), median (25–75 IQR) | |||
| Visit 1 (n = 42) | 1.5 (1.5–1.5) | 1.5 (1.5–1.5) | 0.8 |
| Visit 4 (n = 28) | 1.5 (1.5–2.7) | 1.5 (1.4–40.9) | 0.4 |
| Visit 7 (n = 25) | 1.5 (1.5–1.5) | 20.5 (1.5–44.3) | 0.003 |
| Serum calcium (mmol/L), mean ± SD | |||
| Visit 1 (n = 66) | 2.3 ± 0.06 | 2.3 ± 0.09 | 0.3 |
| Visit 4 (n = 56) | 2.3 ± 0.08 | 2.3 ± 0.06 | 0.4 |
| Visit 7 (n = 49) | 2.3 ± 0.07 | 2.3 ± 0.09 | 0.7 |
| Serum creatinine (mmol/L), mean ± SD | |||
| Visit 1 (n = 66) | 0.06 ± 0.01 | 0.06 ± 0.01 | 0.9 |
| Visit 4 (n = 56) | 0.06 ± 0.01 | 0.06 ± 0.01 | 0.9 |
| Visit 7 (n = 49) | 0.06 ± 0.01 | 0.06 ± 0.01 | 0.07 |
| Urinary calcium: creatinine ratio, mean ± SD | |||
| Visit 1 (n = 65) | 0.1 ± 0.1 | 0.1 ± 0.2 | 0.7 |
| Visit 4 (n = 56) | 0.2 ± 0.1 | 0.2 ± 0.2 | 0.7 |
| Visit 7 (n = ) | 0.2 ± 0.2 | 0.2 ± 0.2 | 0.9 |
| iPTH (pmol/L), median (25–75 IQR) | |||
| Visit 1 (n = 66) | 3.4 (2.9–4.4) | 3.8 (3.3–5.3) | 0.2 |
| Visit 4 (n = 56) | 3.5 (3.0–4.3) | 3.4 (2.4–4.0) | 0.3 |
| Visit 7 (n = 49) | 3.3 (2.4–4.3) | 3.2 (2.2–4.1) | 0.8 |
| Infant | |||
| 25(OH)D (nmol/L), mean ± SD | |||
| Visit 1 (n = 65) | 65.4 ± 19.9 | 64.5 ± 17.2 | 0.8 |
| Visit 4 (n = 56) | 93.9 ± 28.8 | 97.6 ± 25.9 | 0.6 |
| Visit 7 (n = 49) | 96.5 ± 27.2 | 93.5 ± 24.6 | 0.8 |
| D3 (nmol/L), median (25–75 IQR) | |||
| Visit 1 (n = 16) | 10.1 (1.5–20.7) | 16.3 (1.5–20.3) | 0.9 |
| Visit 4 (n = 10) | 13.0 (8.7–41.1) | 26.2 (4.9–47.4) | 0.6 |
| Visit 7 (n = 12) | 27.9 (14.4–85.7) | 12.9 (9.2–25.8) | 0.2 |
| Serum calcium (mmol/L), mean ± SD | |||
| Visit 1 (n = 46) | 2.5 ± 0.08 | 2.5 ± 0.05 | 0.04 |
| Visit 4 (n = 39) | 2.6 ± 0.07 | 2.6 ± 0.07 | 0.5 |
| Visit 7 (n = 34) | 2.5 ± 0.1 | 2.5 ± 0.09 | 0.9 |
| Serum creatinine (mmol/L), mean ± SD | |||
| Visit 1 (n = 50) | 0.02 ± 0.008 | 0.02 ± 0.006 | 0.7 |
| Visit 4 (n = 40) | 0.02 ± 0.006 | 0.02 ± 0.006 | 0.7 |
| Visit 7 (n = 35) | 0.02 ± 0.004 | 0.02 ± 0.006 | 0.09 |
| Urinary calcium: creatinine ratio, mean ± SD | |||
| Visit 1 (n = 57) | 0.9 ± 0.6 | 0.9 ± 0.4 | 0.8 |
| Visit 4 (n = 53) | 0.8 ± 0.5 | 0.7 ± 0.5 | 0.5 |
| Visit 7 (n = 46) | 0.9 ± 0.7 | 0.8 ± 0.8 | 0.7 |
| iPTH (pmol/L), median (25–75 IQR) | |||
| Visit 1 (n = 35) | 3.8 (2.5–5.0) | 3.4 (2.1–4.2) | 0.5 |
| Visit 4 (n = 30) | 2.8 (2.0–3.5) | 1.9 (1.6–2.6) | 0.1 |
| Visit 7 (n = 30) | 2.2 (1.7–3.1) | 1.6 (1.3–1.9) | 0.03 |
Numbers for each laboratory test vary based on blood sample volume obtained at given visit and number of mothers and infants who were still active in study at time of visit.
For measurement of parent compound vitD, this was measured only in a sequential subset of mothers and infants.
*
Student's t-test analyses were used to test for differences in mean laboratory values between treatment groups at each visit. Nonparametric analyses were used to test for differences in median laboratory value (D3 and iPTH) between treatment groups at each visit.