Vitamin D DeficiencyPhase 2NCT02192229
Efficacy of the Dose Regimen of Oral Vitamin D 50,000 IU in the Treatment of Vitamin D Deficiency
A Phase 2 study testing 50.000 IU vitamin D3 (Biodal 50,000 IU) in people with Vitamin D Deficiency, run by Hayat Pharmaceutical Co. PLC at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- 50.000 IU vitamin D3 (Biodal 50,000 IU)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteJordan
- Study dates
- Aug 2014to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Ziad Hawamdeh, Prof contact
About this study
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.
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 .
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- 50.000 IU vitamin D3 (Biodal 50,000 IU), Placebo (to mimic Biodal 50,000 IU)
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50.000 IU vitamin D3 (Biodal 50,000 IU)Drug
Also called Biodal 50,000 IU
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
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | The intervention group will be supplemented with 50.000 IU vitamin D3 every week for 12 consecutive weeks Receives: 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 Receives: Drug: Placebo (to mimic Biodal 50,000 IU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayat Pharmaceutical Co. PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Talal Aburjai, Ph.D., Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192229
- Sponsor's protocol ID
- U1111-1150-5248
- Status last verified
- Jul 2014
- First submitted
- 23 Dec 2013
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02192229
- Acronym / sponsor ID
- U1111-1150-5248
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hayat Pharmaceutical Co. PLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Drug: 50.000 IU vitamin D3 (Biodal 50,000 IU)The intervention group will be supplemented with 50.000 IU vitamin D3 every week for 12 consecutive weeks |
| Placebo group | Placebo comparator | Drug: Placebo (to mimic Biodal 50,000 IU)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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50.000 IU vitamin D3 (Biodal 50,000 IU)Also: Biodal 50,000 IU | Drug | intervention group |
| Placebo (to mimic Biodal 50,000 IU)Placebo Tablet will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging | Drug | Placebo group |
Primary outcome
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.
Time frame: 14 weeks
To assess the dose regimen effectiveness used in this study as per Biodal SmPC.
1 secondary outcome
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.
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziad Hawamdeh, Prof contact
Talal Aburjai, Ph.D. principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50.000 IU vitamin D3 (Biodal 50,000 IU) in people with Vitamin D Deficiency, run by Hayat Pharmaceutical Co. PLC at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziad Hawamdeh, Prof (+962 799 060 814), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.