Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Hojatdost street, Naderi street, Keshavarz Blvd, Tehran, Iran.
Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.
Trials. 2019 Aug 30;20(1):542. doi: 10.1186/s13063-019-3622-y.
The optimal vitamin D intake for nursing mothers with overweight or obesity has not been defined. Vitamin D concentrations are associated with body composition indices, particularly body fat mass. Few studies have investigated the relationship between hypovitaminosis D, obesity, anthropometric status, and body composition in nursing women. Thus, the present study aims to investigate whether vitamin D supplementation during lactation will improve vitamin D status, reduce body fat mass, and improve body composition.
METHODS/DESIGN: In a double-blind, randomized, placebo-controlled, parallel-group trial, after term delivery, 90 healthy women with overweight or obesity will be selected and randomly allocated into three groups to receive 2000 IU/d cholecalciferol (vitamin D3), 4000 IU/d cholecalciferol, or placebo (lactose) for 12 weeks while nursing. Measurements of height, weight, waist circumference, and body composition (fat mass (kg), lean mass (kg), body fat (%), fat mass index, and relative fat mass index) will be taken for all subjects at baseline and after 12 weeks of intervention. In addition, serum 25-hydroxyvitamin D (25(OH)D), parathyroid hormone, calcium, and phosphorus will be measured.
This study is the first investigating the effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in nursing women with overweight or obesity. Our findings will contribute to the growing body of knowledge regarding the role of vitamin D supplementation in obesity, anthropometric status, and body composition in nursing women.
Iranian Registry of Clinical Trials IRCT20140413017254N6 . Registered on 11 April 2018.
目前尚未明确超重或肥胖的哺乳期妇女的最佳维生素 D 摄入量。维生素 D 浓度与身体成分指数有关，尤其是体脂肪量。很少有研究调查哺乳期妇女维生素 D 缺乏症、肥胖、人体测量学状况和身体成分之间的关系。因此，本研究旨在探讨哺乳期补充维生素 D 是否会改善维生素 D 状况、减少体脂肪量并改善身体成分。
方法/设计：在一项双盲、随机、安慰剂对照、平行组试验中，足月分娩后，选择 90 名超重或肥胖的健康哺乳期妇女，将其随机分为三组，分别接受 2000 IU/d 胆钙化醇（维生素 D3）、4000 IU/d 胆钙化醇或安慰剂（乳糖）治疗 12 周。所有受试者在基线和干预 12 周后测量身高、体重、腰围和身体成分（脂肪量（kg）、瘦体重（kg）、体脂肪（%）、脂肪量指数和相对脂肪量指数）。此外，还将测量血清 25-羟维生素 D（25（OH）D）、甲状旁腺激素、钙和磷。
这是第一项研究不同剂量维生素 D 补充对超重或肥胖哺乳期妇女血清钙二醇、人体测量学状况和身体成分影响的研究。我们的研究结果将有助于增加关于维生素 D 补充在肥胖、人体测量学状况和哺乳期妇女身体成分中的作用的知识体系。
伊朗临床试验注册中心 IRCT20140413017254N6 。注册于 2018 年 4 月 11 日。
