肥胖和2型糖尿病患者的维生素D3补充与身体成分：阿联酋随机对照双盲临床试验

Clin Nutr. 2016 Feb;35(1):77-82.

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

Sadiya A, Ahmed SM, Carlsson M, Tesfa Y, George M, Ali SH, Siddieg HH, Abusnana S.

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

Kalmar County Hospital, Kalmar, Sweden.

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.

KEYWORDS: Body composition; Obesity; Type 2 diabetes; United Arab Emirates; Vitamin D

PMID: 25892603

DOI: 10.1016/j.clnu.2015.02.017