| CTRI Number |
CTRI/2024/02/063141 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Evaluation of Three Vitamin D3 Formulations for Sequential Improvement of Vitamin D3 Levels throughout a period of 3-Months. |
|
Scientific Title of Study
|
Comparative Evaluation of Three Vitamin D3 Formulations for Sequential Improvement of Vitamin D3 Levels throughout a period of 3-Months. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshan Pawar |
| Designation |
Alkem Head Medical |
| Affiliation |
Alkem Laboratories Ltd |
| Address |
Alkem Laboratories Ltd
Alkem House Devashish
Adjacent to Matulya centre Senapati Bapat Marg
Lower Parle Mumbai 400 013 Maharashtra India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
9970849872 |
| Fax |
|
| Email |
roshan.pawar@alkem.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshan Pawar |
| Designation |
Alkem Head Medical |
| Affiliation |
Alkem Laboratories Ltd |
| Address |
Alkem Laboratories Ltd
Alkem House Devashish
Adjacent to Matulya centre Senapati Bapat Marg
Lower Parle Mumbai 400 013 Maharashtra India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
9970849872 |
| Fax |
|
| Email |
roshan.pawar@alkem.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Chaudhary |
| Designation |
Director |
| Affiliation |
HREE Research Pvt Ltd |
| Address |
Sr No 63 3A 2 38 1 Plot No 13 Vidya Nagar Makhmalabad Road Nashik Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9890840086 |
| Fax |
|
| Email |
sunil@hree.org |
|
|
Source of Monetary or Material Support
|
| Alkem Laboratories Ltd
ALKEM HOUSE, “Devashishâ€,
Adjacent to Matulya centre, Senapati Bapat Marg,
Lower Parle, Mumbai – 400 013, Maharashtra, India
|
|
|
Primary Sponsor
|
| Name |
Dr Roshan Pawar |
| Address |
Alkem Laboratories Ltd
Alkem House Devashish
Adjacent to Matulya centre Senapati Bapat Marg
Lower Parle Mumbai 400 013 Maharashtra India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HREE Research Pvt Ltd |
Sr No 63 3A 2 38 1 Plot No 13 Vidya Nagar Makhmalabad Road Nashik Maharashtra 422003 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Unnikrishnan A G |
Chellaram Diabetes Institute |
Chellaram Diabetes Institute Clinical research department 1st floor Lalani Quantum Pune Bangalore NH 4 Bavdhan Budruk Pune 411021 Maharashtra India
Pune
MAHARASHTRA |
9689287337
uagcdi@cdi.org.in |
| Dr Hrishikesh Patkar |
Lifepoint Multispecialty Hospital |
Lifepoint Multispecialty Hospital 3 rd floor clinical research department 145 1 Mumbai Bangalore Highway Near Hotel Sayaji Wakad Pune 411057 Maharashtra India
Pune
MAHARASHTRA |
9011267776
patkarhrishikesh9@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Chellaram Diabetes Institute Institutional Ethics Committee |
Approved |
| LPR Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers with vitamin D deficiency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
•Arm A (30 subjects): Oral Vitamin D3 granules
|
Oral Vitamin D3 granules (60000IU) every week
|
| Intervention |
•Arm B (30 subjects): Oral Vitamin D3 softgels |
Oral Vitamin D3 softgels (60000IU) every week |
| Intervention |
•Arm C (30 subjects): Oral Vitamin D3 liquid nano-shots |
Oral Vitamin D3 liquid nano-shots(60000 IU) every week
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing to provide voluntary written informed consent.
2.If an individual is unable to provide informed consent due to reasons such as illiteracy, a Legal Authorized Representative (LAR) will be required to provide written informed consent.
3.Male or Female subjects between 18 to 65 years of age (both inclusive)
4.Vitamin D3 deficiency less than 20 ng/ml
5.Willing and able to comply with the protocol.
|
|
| ExclusionCriteria |
| Details |
1.Any Surgery or hospitalization within 28 days before enrolment
2.Known hypersensitivity to any component of the investigational product and other medications used in this study
3.Patients already on supplementation of calcium and/or Vitamin D
4.Patients suffering from acute or chronic infection(s)
5.BMI greater than 40 Kg/m2
6.Female patients who are pregnant or nursing
7.Patients with H/O concurrent disease or conditions like ESRD, pre-existing liver cell failure, terminally ill cancer or critically ill patients, which in the opinion of the investigator does not allow participation of the patient in this study
8.Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weekly change in vitamin D3 levels up to 1 month
|
3 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total improvement of vitamin D3 levels over the period of 3 months
2.Percentage of people achieving optimal Vitamin D level at week 4,8 and week 12 in 3 groups.
3.Incidence of TEAEs
4. Monthly change in vitamin D3 levels after 3 months in 20 patients (Sub-study)
|
3 Months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is a prospective, open label, Phase IV study. The
study is planned to be conducted in 90 subjects with vitamin D3 deficiency
(levels <20ng/ml) in India. After signing the informed consent form, the
subjects will be screened for confirming the eligibility for study
participation. Patients
will be screened on the basis of Demographics, Physical examination including
vital signs, past medical history, medication history. Eligible
subjects shall be randomized into following 3 arms Arm
A (30 subjects): Oral Vitamin D3 granules (60000IU) every week Arm
B (30 subjects): Oral Vitamin D3 softgels (60000IU) every week Arm
C (30 subjects): Oral Vitamin D3 liquid nano-shots (60000 IU) every week Subjects
will be analyzed for vitamin D3 levels every week as per schedule mentioned in
table. Out
of 30 subjects in Arm B (soft-gel capsule), 20 subjects who are willing to
follow up for 6 more months. Those 20 subjects will be divided in 2 groups. Group
1 (10 subject): Subjects continuing on monthly Vitamin D3 softegel capsule
(60000 IU) Group
2 (10 Subjetcs): Subject without any vitamin D3 therapy Assessments
|
Visit/ Time point
|
Assessments
|
|
Screening
Visit 1
|
Informed consent, eligibility, medical history,
physical examination, baseline serum 25-hydroxyvitamin D levels
|
|
Visit 2 Week 0
(Randomization Visit)
|
Clinical
assessment (Vitamin D levels will not be repeated)
|
|
Visit 3 Week 1
|
Measurement of serum 25-hydroxyvitamin D levels
|
|
Visit 4 Week 2
|
Measurement of serum 25-hydroxyvitamin D levels
|
|
Visit 5 Week 3
|
Measurement of serum 25-hydroxyvitamin D levels
|
|
Visit 6 Week 4
|
Measurement of serum 25-hydroxyvitamin D levels
|
|
Visit 7 Week 8
|
Measurement of serum 25-hydroxyvitamin D levels
|
|
Visit 8 Week 12 (EOS)
|
Final assessment of serum 25-hydroxyvitamin D
levels
|
|