Status:
UNKNOWN
Efficacy of the Dose Regimen of Oral Vitamin D 50,000 IU in the Treatment of Vitamin D Deficiency
Lead Sponsor:
Hayat Pharmaceutical Co. PLC
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
Brief Summary
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 popu...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02192229
Start Date
August 1 2014
End Date
November 1 2014
Last Update
July 16 2014
Active Locations (1)
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1
Jordan University Hospital
Amman, Jordan