Efficacy of the Dose Regimen of Oral Vitamin D 50,000 IU in the Treatment of Vitamin D Deficiency

NCT02192229 | Unknown Phase 2 DMC

• 1 other identifier: U1111-1150-5248
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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 .

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effectiveness of the dose regimen considered in this study as the product SmPC which will be measured through the assessment of serum 25 (OH)D along the trial period.

  To assess the dose regimen effectiveness used in this study as per Biodal SmPC.

  14 weeks

Secondary Outcomes (1)

• Assessing the level of (Urine analysis, Hematology ,Kidney Function Test,Liver Function Test, Virology, chemistry, 25(OH)D, Ca, Mg, Phosphate, Parathyroid hormone, Alkaline Phosphatase ) and reporting any adverse events through the trial period.

  14 weeks

Study Arms (2)

intervention group

ACTIVE COMPARATOR

The intervention group will be supplemented with 50.000 IU vitamin D3 every week for 12 consecutive weeks

Drug: 50.000 IU vitamin D3 (Biodal 50,000 IU)

Placebo group

PLACEBO COMPARATOR

The placebo group will receive placebo Tablet which will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging

Drug: Placebo (to mimic Biodal 50,000 IU)

Interventions

50.000 IU vitamin D3 (Biodal 50,000 IU) DRUG

Also known as: Biodal 50,000 IU

intervention group

Placebo (to mimic Biodal 50,000 IU) DRUG

Placebo Tablet will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging

Placebo group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hayat Pharmaceutical Co. PLC: lead

Study Sites (1)

Jordan University Hospital

Amman, Jordan

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Talal Aburjai, Ph.D.

  University of Jordan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziad Hawamdeh, Prof

CONTACT

+962 799 060 814

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: July 16, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

JO (1)