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阿联酋肥胖和2型糖尿病患者补充维生素D3与身体成分:一项随机对照双盲临床试验

Vitamin D3 supplementation and body composition in persons with obesity and type 2 diabetes in the UAE: A randomized controlled double-blinded clinical trial.

作者信息

Sadiya Amena, Ahmed Solafa M, Carlsson Martin, Tesfa Yohannes, George Mary, Ali Samia H, Siddieg Hisham H, Abusnana Salah

机构信息

Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates.

Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates.

出版信息

Clin Nutr. 2016 Feb;35(1):77-82. doi: 10.1016/j.clnu.2015.02.017. Epub 2015 Mar 24.

DOI:10.1016/j.clnu.2015.02.017
PMID:25892603
Abstract

BACKGROUND & AIM: The co-existence of vitamin D deficiency with obesity and type 2 diabetes is highly prevalent in the United Arab Emirates. We do not have studies evaluating the vitamin D dose response and sufficiency, and if sufficient substitution dose during a longer period could decrease obesity or change fat distribution in obese type 2 diabetic vitamin D deficient Emiratis.

METHODS

A randomized double-blind clinical trial was conducted for 6 months followed by another 6 months of un-blinded follow up with 87 obese, type 2 diabetic participants. Serum 25-hydroxy vitamin D (S-25(OH)D), anthropometric data, and life-style factors such as diet and sunlight exposure were measured. The study was executed in 3 phases in two arms vitamin D arm (n = 45) and placebo arm (n = 42); in Phase 1 the vitamin D arm received 6000 IU vitamin D3/day (3 months) followed by Phase 2 with 3000 IU vitamin D3/day. During follow up (phase 3) both the arms were un-blinded and supplemented with 2200 IU vitamin D3/day for another 6 months.

RESULTS

At the baseline a significant (p < 0.01) positive association between body fat mass and body weight (r = 0.97) muscle mass (r = 0.47), water mass (r = 0.54), waist circumference (r = 0.82) and serum PTH (r = 0.28) was observed. On supplementation no significant changes in anthropometric dimensions was observed. S-25(OH) D peaked in phase 1 (77.2 ± 30.1 vs 28.5 ± 9.2, p = 0.003) followed by a decrease in phase 2 (62.3 ± 20.8, p = 0.006) paralleled by a decrease in parathyroid hormone in phase 2 (5.9 ± 2.4 vs 4.5 ± 1.8, p < 0.01) compared to baseline in vitamin D group.

CONCLUSION

This study shows no significant influence of vitamin D supplementation on weight, fat mass or waist circumference in type 2 diabetic obese vitamin D deficient participants of Arab ethnicity after one year. Despite a relatively high daily dose of vitamin D3 we did not achieve target levels of S-25(OH)D above 75 nmol/L in this population. However, supplementation was safe, improved s- 25 (OH)D also reducing the incidence of eucalcemic parathyroid hormone elevation.

CLINICAL TRIAL REGISTRY

ClinicalTrials.gov Identifier: NCT02101151.

摘要

背景与目的

在阿拉伯联合酋长国,维生素D缺乏与肥胖及2型糖尿病并存的情况极为普遍。我们尚未开展评估维生素D剂量反应及充足性的研究,也不清楚在较长时期内给予足够的替代剂量是否能减轻肥胖或改变肥胖的2型糖尿病维生素D缺乏阿联酋人的脂肪分布。

方法

对87名肥胖的2型糖尿病参与者进行了为期6个月的随机双盲临床试验,随后进行另外6个月的非盲随访。测量了血清25-羟维生素D(S-25(OH)D)、人体测量数据以及饮食和阳光照射等生活方式因素。该研究分三个阶段在两个组进行,即维生素D组(n = 45)和安慰剂组(n = 42);在第一阶段,维生素D组每天服用6000 IU维生素D3(3个月),随后在第二阶段每天服用3000 IU维生素D3。在随访阶段(第三阶段),两组均不再设盲,继续每天补充2200 IU维生素D3,为期6个月。

结果

在基线时,观察到体脂量与体重(r = 0.97)、肌肉量(r = 0.47)、水量(r = 0.54)、腰围(r = 0.82)和血清甲状旁腺激素(r = 0.28)之间存在显著(p < 0.01)正相关。补充维生素D后,人体测量指标未观察到显著变化。在维生素D组中,S-25(OH)D在第一阶段达到峰值(77.2 ± 30.1 vs 28.5 ± 9.2,p = 0.003),随后在第二阶段下降(62.3 ± 20.8,p = 0.006),同时甲状旁腺激素在第二阶段也较基线下降(5.9 ± 2.4 vs 4.5 ± 1.8,p < 0.01)。

结论

本研究表明,在为期一年的时间里,补充维生素D对阿拉伯族裔的2型糖尿病肥胖维生素D缺乏参与者的体重、脂肪量或腰围没有显著影响。尽管维生素D3的每日剂量相对较高,但我们并未使该人群的S-25(OH)D达到高于75 nmol/L的目标水平。然而,补充维生素D是安全的,可提高S-25(OH)D水平,同时也降低了血钙正常的甲状旁腺激素升高的发生率。

临床试验注册

ClinicalTrials.gov标识符:NCT02101151。

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