超重/肥胖且维生素D水平欠佳的非裔美国人中，维生素D生物标志物对每月补充维生素D3的剂量和时间反应：一项安慰剂对照随机临床试验
Dose and time responses of vitamin D biomarkers to monthly vitamin D3 supplementation in overweight/obese African Americans with suboptimal vitamin d status: a placebo controlled randomized clinical trial.
作者信息
Bhagatwala Jigar, Zhu Haidong, Parikh Samip J, Guo De-Huang, Kotak Ishita, Huang Ying, Havens Robyn, Pham Michael, Afari Eric, Kim Susan, Cutler Christopher, Pollock Norman K, Dong Yutong, Raed Anas, Dong Yanbin
机构信息
Georgia Prevention Institute, Medical College of Georgia, Georgia Regents University, Building HS-1640, Augusta, 30912-3715 GA USA ; Department of Internal Medicine, Medical College of Georgia, Georgia Regents University, Augusta, GA USA.
Georgia Prevention Institute, Medical College of Georgia, Georgia Regents University, Building HS-1640, Augusta, 30912-3715 GA USA.
出版信息
BMC Obes. 2015 Jul 4;2:27. doi: 10.1186/s40608-015-0056-2. eCollection 2015.
BACKGROUND
A critical need exists to better understand the physiological sequel of vitamin D supplementation in obese individuals and African Americans. The aim was to comprehensively evaluate dose- and time-responses of a panel of vitamin D biomarkers to vitamin D supplements in this population.
METHODS
We conducted a 16-week randomized, double-blinded, and placebo-controlled clinical trial. Seventy overweight/obese African Americans (age 13-45 years, 84 % females) with 25-hydroxyvitamin D [25(OH)D] concentrations ≤20 ng/mL were randomly assigned to receive a supervised monthly oral vitamin D3 of 18,000 IU (600 IU/day, n = 17), 60,000 IU (2000 IU/day, n = 18), 120,000 IU (~4000 IU/day, n = 18), or placebo (n = 17).
RESULTS
There were significant dose- and time-responses of circulating 25(OH)D, 1,25-dihydroxyvitamin D [1,25(OH)2D], and intact parathyroid hormone (iPTH), but not fibroblast growth factor-23 (FGF-23), phosphorus and urine calcium to the vitamin D supplements. The mean 25(OH)D concentrations in the 2000 IU and 4000 IU groups reached ≥30 ng/mL as early as 8-weeks and remained at similar level at 16-weeks. The increase of 25(OH)D was significantly higher in the 4000 IU group than all the other groups at 8-weeks. The increase of 1,25(OH)2D was significantly higher in the 2000 IU and 4000 IU groups than the placebo at 8-weeks. Only the 4000 IU compared to the placebo significantly reduced iPTH at 8- and 16-weeks.
CONCLUSIONS
Our RCT, for the first time, comprehensively evaluated time- and dose- responses of vitamin D supplementation in overweight/obese African Americans with suboptimal vitamin D status. Circulating 25(OH)D, 1,25(OH)2D, and iPTH, but not FGF-23, phosphorus and urine calcium, respond to vitamin D supplementation in a time- and dose-response manner. By monthly dosing, 2000 IU appears to be sufficient in achieving a 25(OH)D level of 30 ng/mL in this population. However, importantly, 4000 IU, rather than 2000 IU, seems to suppress iPTH. If replicated, these data might be informative in optimizing vitamin D status and providing individualized dosing recommendation in overweight/obese African Americans.
TRIAL REGISTRATION
ClinicalTrials.gov number: NCT01583621, Registered on April 3, 2012.
背景
迫切需要更好地了解肥胖个体和非裔美国人补充维生素D后的生理后果。目的是全面评估该人群中一组维生素D生物标志物对维生素D补充剂的剂量和时间反应。
方法
我们进行了一项为期16周的随机、双盲、安慰剂对照临床试验。70名超重/肥胖的非裔美国人（年龄13 - 45岁，84%为女性），其25 - 羟基维生素D [25(OH)D]浓度≤20 ng/mL，被随机分配接受每月一次的监督口服维生素D3，剂量分别为18,000 IU（约600 IU/天，n = 17）、60,000 IU（约2000 IU/天，n = 18）、120,000 IU（约4000 IU/天，n = 18）或安慰剂（n = 17）。
结果
循环中的25(OH)D、1,25 - 二羟基维生素D [1,25(OH)2D]和完整甲状旁腺激素（iPTH）对维生素D补充剂有显著的剂量和时间反应，但成纤维细胞生长因子 - 23（FGF - 23）、磷和尿钙没有。2000 IU和4000 IU组的平均25(OH)D浓度早在8周时就达到≥30 ng/mL，并在16周时保持在相似水平。在8周时，4000 IU组的25(OH)D升高幅度显著高于所有其他组。在8周时，2000 IU和4000 IU组的1,25(OH)2D升高幅度显著高于安慰剂组。仅4000 IU组与安慰剂组相比，在8周和16周时显著降低了iPTH。
结论
我们的随机对照试验首次全面评估了维生素D状态欠佳的超重/肥胖非裔美国人补充维生素D的时间和剂量反应。循环中的25(OH)D、1,25(OH)2D和iPTH对维生素D补充剂有时间和剂量反应，而成纤维细胞生长因子 - 23、磷和尿钙没有。通过每月给药，2000 IU似乎足以使该人群的25(OH)D水平达到30 ng/mL。然而，重要的是，4000 IU似乎比2000 IU更能抑制iPTH。如果得到重复验证，这些数据可能有助于优化超重/肥胖非裔美国人的维生素D状态并提供个性化给药建议。
试验注册
ClinicalTrials.gov编号：NCT01583621，于2012年4月3日注册。
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