Abstract:

The main objective of the proposed study is to examine the Safety and Efficacy Evaluation of the Dose Regimen of Vitamin D 50,000 IU (Biodal) tablet supplementation in the treatment of population with vitamin D deficiency.

A randomized, double-blind placebo, Parallel design comparing vitamin D with Placebo will be conducted on 60 Healthy males and females with vitamin D deficiency, age from 18 to 49 years who attend the rehabilitation clinics at Jordan University Hospital .Participants who met the inclusion criteria will be asked to sign an informed witnessed consent form. Results obtained are expected to assess the safety and efficacy of the dose regimen used in this study as per Biodal SmPC. This study will also contribute to the global body of knowledge in this field. The major findings generated from this study could open certain avenues for further research through the association of the status of vitamin D in serum .

The study design will be a prospective randomized double blind parallel design comparing Vitamin D with Placebo. This study will be conducted in Jordan University Hospital (JUH). The participants will be Healthy males and females with vitamin D deficiency (18 to 49 years old). All eligible males and females who agree to participate in the study will sign an informed witnessed consent form at the beginning of the study. The expected duration of participants participation will be around 120 days and the number of visits for each participant will be 6 visits divided as follows; the first visit will be before 7 days of the initiation of the trial (screening period), the second on day zero of the treatment period, the third on day 30, the fourth on day 60, the fifth on day 90 and the sixth or the last visit will be on day 104 (after 14 days of the last treatment). Therefore the treatment period will be 90 days and the post treatment follow up period will be 14 days.

Inclusion criteria:

• Subject is willing and able to give voluntary informed consent for participation in the study.
• Ethnic group (Caucasian).
• Healthy males or females aged between 18 and 49 years old.
• Normal weight (BMI 18.5-25kg/m2).
• Physical examination being assessed and accepted by the attending physician.
• Systolic blood pressure within the normal range (90-140) mmHg.
• Diastolic blood pressure within the normal range (60-90) mmHg.
• Heart rate within the normal range (60-100 beats/min).
• Oral body temperature within the normal range (35.9 - 37.6 Cº).
• Diagnosed with vitamin D deficiency with 25-OH Vitamin D level < 20ng/ml.
• All laboratory tests which including : Urine analysis, Hematology (Hb, Packed Cell Volume, Red Blood Cell, Mean Corpuscular Hemoglobin , Mean Corpuscular Hemoglobin Concentration , Mea Corpuscular Volume, Leukocytes, Lymphocytes, Eosinophils, Basophils, Monocytes, Neutrophils, Platelet count), Kidney function tests, Liver function test, Virology, Clinical chemistry, Ca, Mg, PO4, PTH , Alkaline Phosphatase and pregnancy test for married females ,results within the normal reference range.
• Able and willing to comply with all study requirements.

Exclusion Criteria

The subject may not enter the study if ANY of the following apply:

• Female subjects who is pregnant, lactating or planning pregnancy during the course of the study.
• Ethnic group non Caucasian.
• Males and Females aged <18 or >49 years old.
• Underweight, overweight and obese Females and males
• Males and Females diagnosed with diabetes, hypothyroidism, hyperthyroidism, liver disease, renal dysfunction, cardiovascular diseases including hypertension, androgen-secreting tumor, Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia, and/or virilism.
• Known history or presence of food allergies or intolerance (e.g dairy products or gluten containing food), or any known condition that could interfere with the absorption, distribution, metabolism or execration of drugs.
• History of drug or alcohol abuse, smoking of 10 cigarettes or more (or equivalent) per day.
• Subjects who took medications known to affect metabolic parameters, such as metformin and corticosteroid drugs, vitamin D and calcium.
• Participation in another clinical or bioequivalence study within 90 days prior to the start of this study period.
• Subjects with abnormal ECG.
• Subjects with any abnormal laboratory results except 25 OH-Cholecalciferol level.