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

Primary Purpose

Vitamin D Deficiency

Status

Unknown status

Phase

Phase 2

Locations

Jordan

Study Type

Interventional

Intervention

50.000 IU vitamin D3 (Biodal 50,000 IU)

Placebo (to mimic Biodal 50,000 IU)

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intervention group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Evaluation of the safety of the dose regimen of vitamin D3 supplementation which will be measured by assessing the level of laboratory tests which including (Urine analysis Hematology Kidney function tests, Liver function test, Virology, Clinical chemistry, 25(OH)D, Ca, Mg, PO4, PTH , Alkaline Phosphatase and pregnancy test for married females), Physical examinations ,ECG examination, vital signs, and reporting any adverse events through the trial period.

Full Information

NCT ID

NCT02192229

First Posted

December 23, 2013

Last Updated

July 14, 2014

Sponsor

Hayat Pharmaceutical Co. PLC

1. Study Identification

Unique Protocol Identification Number

NCT02192229

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (undefined)

Primary Completion Date

November 2014 (Anticipated)

Study Completion Date

November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hayat Pharmaceutical Co. PLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 .

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

50.000 IU vitamin D3 (Biodal 50,000 IU)

Other Intervention Name(s)

Biodal 50,000 IU

Intervention Type

Drug

Intervention Name(s)

Placebo (to mimic Biodal 50,000 IU)

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

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

Time Frame

14 weeks

Secondary Outcome Measure Information:

Title

Description

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ziad Hawamdeh, Prof

Phone

+962 799 060 814

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Talal Aburjai, Ph.D.

Organizational Affiliation

University of Jordan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jordan University Hospital

City

Amman

Country

Jordan

12. IPD Sharing Statement

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

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