title: Vitamin D3 supplementation and body composition in persons with obesity and type 2 diabetes in the UAE: A randomized controlled double-blinded clinical trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02101151.
authors.affiliation: Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates. Electronic address: amena.sadiya@rcdr.ae.
authors.forename: Amena
authors.initials: A
authors.lastname: Sadiya
authors.affiliation: Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates.
authors.forename: Solafa M
authors.initials: SM
authors.lastname: Ahmed
authors.affiliation: Kalmar County Hospital, Kalmar, Sweden.
authors.forename: Martin
authors.initials: M
authors.lastname: Carlsson
authors.affiliation: Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates.
authors.forename: Yohannes
authors.initials: Y
authors.lastname: Tesfa
authors.affiliation: Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates.
authors.forename: Mary
authors.initials: M
authors.lastname: George
authors.affiliation: Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates.
authors.forename: Samia H
authors.initials: SH
authors.lastname: Ali
authors.affiliation: Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates.
authors.forename: Hisham H
authors.initials: HH
authors.lastname: Siddieg
authors.affiliation: Rashid Centre for Diabetes and Research, Ajman, United Arab Emirates.
authors.forename: Salah
authors.initials: S
authors.lastname: Abusnana
mesh_terms: D000328:Adult; D000359:Aftercare; D001823:Body Composition / Q000187:drug effects*; D001835:Body Weight; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000150:complications / Q000188:drug therapy; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood* / Q000150:complications / Q000188:drug therapy; D010281:Parathyroid Hormone / Q000097:blood; D014479:United Arab Emirates; D014808:Vitamin D Deficiency / Q000097:blood / Q000150:complications / Q000188:drug therapy; D055105:Waist Circumference
chemical_list: D010281:Parathyroid Hormone; D002762:Cholecalciferol
keywords: Body composition; Obesity; Type 2 diabetes; United Arab Emirates; Vitamin D