Table 2.
Primary and secondary outcomes in the two intervention groups and intervention effects at 24–28 and 35–37 weeks of pregnancy.
| Vitamin D n = 77 |
Placebo n = 67 |
Vit.D vs. Placebo $ | Vit.D vs. Placebo $$ | |||
|---|---|---|---|---|---|---|
| 24–28 weeks | Mean | SD | Mean | SD | mean difference (95% CI) |
Adjusted mean difference (95% CI) |
| Gestational age, weeks | 26.5 | 1.4 | 26.3 | 1.6 | 0.3 (−0.2; 0.8) | 0.3 (−0.2; 0.8) |
| Triglyceride, mmol/L | 1.86 | 0.56 | 1.82 | 0.59 | 0.08 (−0.08; 0.24) | 0.05 (−0.13; 0.22) |
| LDL-C, mmol/L | 3.99 * | 0.96 | 3.55 * | 0.83 | 0.20 (−0.03; 0.43) | 0.20 (−0.05; 0.44) |
| HDL-C, mmol/L | 1.47 | 0.21 | 1.45 | 0.28 | 0.00 (−0.05; 0.05) | 0.01 (−0.05; 0.06) |
| FFA, mmol/L | 0.54 | 0.22 | 0.52 | 0.17 | 0.014 (−0.047; 0.076) | 0.015 (−0.053; 0.083) |
| 3BHB, mmol/L | 0.087 | 0.097 | 0.053 | 0.084 | 0.018 (−0.012; 0.048) | 0.007 (−0.027; 0.040) |
| Leptin, ng/dL | 33.0 | 17.5 | 33.0 | 15.3 | −0.4 (−5.1; 4.3) | 0.9 (−3.6; 5.4) |
| Calcium, mmol/L | 2.1 | 0.3 | 2.1 | 0.4 | 0.02 (−0.07; 0.10) | −0.02 (−0.08; 0.05) |
| Albumin-corrected Calcium, mmol/L | 2.2 | 0.4 | 2.2 | 0.5 | 0.04 (−0.08; 0.15) | −0.01 (−0.03; 0.05) |
| 25-OH-D2, nmol/L | 2.9 | 4.3 | 3.3 | 4.7 | −0.6 (−2.0; 0.8) | −0.7 (−2.3; 0.9) |
| 25-OH-D3, nmol/L | 116.6 *** | 35.2 | 78.7 *** | 39.3 | 35.1 (23.3; 46.9) *** | 34.3 (22.5; 46.2) *** |
| 25-OH-D total, nmol/L | 119.5 *** | 35.5 | 82.0 *** | 39.4 | 34.3 (22.4; 46.1) *** | 33.4 (21.5; 45.2) *** |
| Neck circumference, cm | 36.6 | 2.2 | 36.6 | 2.0 | 0.1 (−0.2; 0.5) | 0.1 (−0.3; 0.4) |
| Weight gain, kg | 4.1 | 3.1 | 3.9 | 2.6 | 0.2 (−0.7; 1.1) | −0.4 (−1.3; 0.6) |
| Vitamin D n = 70 |
Placebo n = 59 |
Vit.D vs. Placebo $ | Vit.D vs. Placebo $$ | |||
| 35–37 weeks | Mean | SD | Mean | SD | mean difference (95% CI) |
Adjusted mean difference (95% CI) |
| Gestational age, wks | 35.9 | 0.8 | 35.9 | 0.9 | 0.0 (−0.3; 0.3) | 0.0 (−0.3; 0.3) |
| Triglyceride, mmol/L | 2.49 | 0.73 | 2.29 | 0.80 | 0.19 (−0.08; 0.46) | 0.11 (−0.18; 0.39) |
| LDL-C, mmol/L | 4.06 | 1.01 | 3.68 | 0.93 | 0.17 (−0.14; 0.48) | 0.17 (−0.14; 0.48) |
| HDL-C, mmol/L | 1.41 | 0.25 | 1.44 | 0.30 | −0.00 (−0.08; 0.07) | −0.00 (−0.09; 0.08) |
| FFA, mmol/L | 0.54 | 0.19 | 0.54 | 0.20 | −0.01 (−0.08; 0.07) | −0.04 (−0.12; 0.05) |
| 3BHB, mmol/L | 0.079 | 0.058 | 0.062 | 0.074 | 0.016 (−0.012; 0.043) | 0.012 (−0.019; 0.042) |
| Leptin, ng/dL | 32.7 | 14.3 | 31.7 | 13.0 | 0.38 (−4.6; 5.4) | 1.2 (−3.9; 6.4) |
| Calcium, mmol/L | 2.2 | 0.2 | 2.1 | 0.4 | 0.10 (−0.22; 0.41) | 0.00 (−0.05; 0.05) |
| Albumin-corrected Calcium, mmol/L | 2.3 | 0.3 | 2.2 | 0.4 | 0.04 (−0.08; 0.15) | −0.25 (−0.12; 0.07) |
| 25-OH-D2, µg/L | 2.3 | 4.1 | 2.9 | 4.5 | −1.1 (−2.5; 0.3) | −1.3 (−2.8; 0.3) |
| 25-OH-D3, µg/L | 120.7 *** | 38.9 | 81.7 *** | 40.3 | 38.9 (24.6; 53.1) *** | 36.2 (19.9; 52.5) *** |
| 25-OH- D total, µg/L | 123.0 *** | 38.8 | 84.6 *** | 39.8 | 37.9 (23.8; 51.9) *** | 34.9 (18.8; 51.0) *** |
| Skinfold biceps, mm | 21.0 | 9.0 | 20.8 | 8.0 | −0.1 (−2.9; 2.9) | 0.2 (−3.2; 3.5) |
| Skinfold triceps, mm | 27.4 | 7.1 | 27.7 | 8.1 | −0.4 (−2.7; 1.9) | −1.0 (−3.6; 1.7) |
| Skinfold subscapular, mm | 29.6 | 8.4 | 29.7 | 10.2 | 0.8 (−2.0; 3.6) | −0.2 (−3.5; 3.2) |
| Skinfold supra-iliac, mm | 34.7 | 13.6 | 33.7 | 11.7 | −0.4 (−4.1; 3.3) | −3.3 (−7.6, 1.2) |
| Sum of skinfolds, cm | 112.7 | 28.1 | 111.9 | 30.4 | −0.5 (−9.0; 8.0) | −5.6 (−15.5; 4.3) |
| Fat percentage, % | 31.3 | 3.0 | 31.3 | 3.9 | 0.0 (−1.0; 1.0) | −0.6 (−1.8; 0.6) |
| Neck circumference, cm | 36.8 | 2.6 | 36.8 | 2.1 | 0.1 (−0.2; 0.5) | 0.1 (−0.3; 0.4) |
| Weight gain, kg § | 7.7 | 4.6 | 8.0 | 6.1 | −0.3 (−2.1; 1.5) | −1.6 (−3.2; 0.1) |
* p < 0.05, *** p < 0.001, SD = standard deviation, CI = confidence interval, LDL-C = Low Density Lipoprotein cholesterol, HDL-C = High Density Lipoprotein cholesterol, FFA = free fatty acid, 3BHB = beta-hydroxy butyrate, 25OH D = 25 hydroxyvitamin. $ adjusted for baseline values of the outcome variable, $$ adjusted for baseline values of the outcome variable, maternal age, BMI at baseline, weight gain until time of examination, gestational week, educational level, insulin resistance at time of examination (HOMA Index), self-reported food intake (portion size), self-reported physical activity, maternal smoking, study site. § Weight gain was adjusted for BMI at baseline in the unadjusted model and for maternal age, BMI at baseline, gestational week, educational level, insulin resistance at time of examination (HOMA Index), self-reported food intake (portion size), self-reported physical activity, maternal smoking, study site in the adjusted model.