Dougherty Kelly A, Bertolaso Chiara, Schall Joan I, Smith-Whitley Kim, Stallings Virginia A
*The School of Health Sciences, The Richard Stockton College of New Jersey, Galloway, NJ †University Hospital Umberto I, Sapienza University, Rome, Italy ‡Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition §Division of Hematology, Children's Hospital of Philadelphia ∥Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
J Pediatr Hematol Oncol. 2015 Jul;37(5):e308-15. doi: 10.1097/MPH.0000000000000355.
Suboptimal vitamin D (vit D) status (<32 ng/mL) is ubiquitous among African American children with type SS sickle cell disease (SCD-SS). The vit D supplemental dose to normalize vit D status is unknown. Five to 20-year-old African American children with (n=21) and without (n=23) SCD-SS were randomized to vit D3 supplementation (4000 or 7000 IU/d) and evaluated at 6 and 12 weeks for changes in vit D and SCD status. A dose was considered unsafe if serum calcium was elevated associated with elevated serum 25 hydroxyvitamin D (25(OH)D). At baseline 95% of subjects with SCD-SS and 87% of healthy controls had suboptimal vit D status (mean±SD, 19.2±7.2 and 22.3±9.3 ng/mL, respectively). After 12 weeks supplementation, both D3 doses were safe and well tolerated. Neither group achieved the a priori efficacy criterion of 25(OH)D≥32 ng/mL in >80% of subjects (45% in SCD-SS and 63% in controls). However, for both subjects with SCD-SS and healthy subjects by 12 weeks, deficient (<20 ng/mL) vit D status was eliminated only in those receiving 7000 IU/d. For subjects with SCD-SS, by 12 weeks there was a significant (all P<0.05) increase in fetal hemoglobin, decrease in high-sensitivity C-reactive protein, and reduction in the percentage of subjects with a high platelet count.
在患有SS型镰状细胞病（SCD-SS）的非裔美国儿童中，维生素D（vit D）水平未达最佳状态（<32 ng/mL）的情况普遍存在。使vit D状态正常化所需的vit D补充剂量尚不清楚。将21名患有SCD-SS的5至20岁非裔美国儿童和23名未患SCD-SS的非裔美国儿童随机分为维生素D3补充组（4000或7000 IU/天），并在第6周和第12周评估vit D和SCD状态的变化。如果血清钙升高且伴有血清25-羟基维生素D（25(OH)D）升高，则认为该剂量不安全。基线时，95%的SCD-SS受试者和87%的健康对照者vit D状态未达最佳（分别为均值±标准差，19.2±7.2和22.3±9.3 ng/mL）。补充12周后，两种D3剂量均安全且耐受性良好。两组均未在超过80%的受试者中达到25(OH)D≥32 ng/mL的先验疗效标准（SCD-SS组为45%，对照组为63%）。然而，对于SCD-SS受试者和健康受试者，到第12周时，只有接受7000 IU/天的受试者消除了vit D缺乏状态（<20 ng/mL）。对于SCD-SS受试者，到第12周时，胎儿血红蛋白显著升高（所有P<0.05），高敏C反应蛋白降低，血小板计数高的受试者百分比降低。
