Vitamin D and placebo pills were
manufactured to have similar shape, color, size, smell and taste. The study medications were stored at the
AUBMC pharmacy and placebo and/or active vitamin D pills were be dispensed in
boxes corresponding to the above described doses. Boxes were sequentially numbered as per the
random allocation list. All study
participants, research assistants, health care providers, principal investigator,
co-investigators and biostatistician were unware of the study drug assignments
throughout the trial.
Elderly subjects (≥65 years) overweight (BMI > 25 kg /m2) non diabetic were recruited through Out Patient Department (OPD), clinics, and through ads posted in various hospital areas at AUBMC and Hotel Dieu de France, Rafic Hariri Government hospital. We also received referrals from dispensaries of the Ministry of Social Affairs from the greater Beirut Area and the mountains.
The randomization was stratified by center and gender with treatment assignment based on matching subjects’ baseline serial ID number with treatment code. Serial ID odd numbers assigned to High dose vitamin D and Serial ID even numbers assigned to Low dose vitamin D. Both study groups were received 1000mg calcium and 600IU vitamin D, which are equivalent to the recommended doses as per the Institute of Medicine
Elderly subjects (≥65 years) overweight (BMI > 25 kg /m2) non diabetic
Exclusion criteria included subjects with impaired glucose tolerance on medication (FBS≥100 mg/dl, HbA1c= 5.7-6.4%), Diabetic (FBS ≥126 mg/dl, HbA1c≥6.5%), presence of a chronic disease or major organ failure such as severe heart failure (stage III, IV), liver failure and cirrhosis, kidney failure (GFR<30 ml/min), cancer, autoimmune disease, conditions or intake of medications known to affect bone metabolism, osteomalacia, history of kidney stones, a baseline vitamin D level of less than 10 ng/ml and history of fragility fractures or an overall fracture risk based on FRAX of >10%.