| CTRI Number |
CTRI/2023/03/050877 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the efficacy and safety of Magnesium and Vitamin D supplement as an additional therapy to anti diabetic drugs in Type 2 Diabetic Patients. |
|
Scientific Title of Study
|
A Randomized, Multicenter, Double Blind, Placebo Controlled prospective study to evaluate the Efficacy and Safety of Magnesium and Vitamin D Supplement as an add on therapy to Oral Hypoglycemic agents (OHA) in Type 2 Diabetic Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PL/CS/22-23/01 Version 1.0 Dated 19 Jan 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G M Prasad |
| Designation |
Consultant diabetologist |
| Affiliation |
Pranav Diabetes Center |
| Address |
57/1, Nanda Complex, Rammurthy Nagar Main Road, Banaswadi, Bangalore
Bangalore
KARNATAKA
560043
India |
| Phone |
9731911630 |
| Fax |
|
| Email |
drgmprasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amal K Maji |
| Designation |
Scientific Adviser |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd. |
| Address |
No.252, 13th Cross, Wilson Garden, Bangalore
Bangalore
KARNATAKA
560027
India |
| Phone |
08042115562 |
| Fax |
|
| Email |
admin@xplorahealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd. |
| Address |
No.252, 13th Cross, Wilson Garden, Bangalore
Bangalore
KARNATAKA
560027
India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
|
Source of Monetary or Material Support
|
| Pharmed Limited
Sattva Mindcomp Tech Park, Ground Floor,
Office 1, 149-A, EPIP II Phase,
Whitefield Industrial Area, Bengaluru - 560066 |
|
|
Primary Sponsor
|
| Name |
Pharmed Limited |
| Address |
Sattva Mindcomp Tech Park, Ground Floor, Office 1,
149-A, EPIP II Phase, Whitefield Industrial Area, Bengaluru - 560 066 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dilip Kadam |
Care Multispeciality Hospital |
General Medicine Department, Care Multispeciality Hospital Kotle Arcade, Pune – Nagar Road, Wagholi, Pune – 412207
Pune
MAHARASHTRA |
7066115411
dr.dilipkadam12@gmail.com |
| Dr G M Prasad |
Pranav Diabetes Center |
57/1, Nanda Complex, Rammurthy Nagar Main Road, Banaswadi, Banglore
Bangalore
KARNATAKA |
9731911630
drgmprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Care Multispeciality Hospital Institutional Ethics Committee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium (250 mg) and Vitamin D (600IU) tablet |
Oral administration of 1 tablet after breakfast for 90 days. |
| Comparator Agent |
Placebo |
Oral administration of 1 tablet after breakfast for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of either sex aged between 18 to 70 years.
2. Participants diagnosed with type 2 diabetes having HbA1c>6.5% who are on any antidiabetic drugs (mono or poly OHA)
3. Willing to participate and able to provide signed informed consent.
4. Having BMI between 23 to 40 kg/m2. |
|
| ExclusionCriteria |
| Details |
1. Type 1 diabetes or T2DM subject on insulin treatment/and any other supplement for glucose control.
2.Subjects those who in addition to OHA (single or poly, take any herbal/Ayurvedic or home remedies as add on to their OHA.
3. Subjects suffering from complications of diabetes such as diabetic neuropathy, nephropathy, retinopathy, etc. that require urgent treatment.
4. Subjects with uncontrolled hypertension (with or without medication >140/90 mmHg after 5 min of rest).
5. Subjects with an established diagnosis of coronary artery disease (CAD) requiring any medical procedure in the next 6 months, such as angioplasty or bypass surgery; or subjects with New York Heart Association (NYHA) classification III and IV, cardiac insufficiency, or any other clinically significant cardiovascular disease.
6. Subjects with concurrent hepatic dysfunction (defined as AST and/or ALT > 2 times the upper limit of normal) or renal dysfunction (defined as S. creatinine > greater than the upper limit of normal), uncontrolled pulmonary dysfunction (asthmatics and COPD patients).
7. Pregnant/lactating women and women of childbearing potential who do not agree to remain abstinent or use appropriate contraception during the treatment period and for 4 weeks after the end of study treatment.
8. Active user of systemic or oral steroids, oral contraceptive pills, or estrogen replacement therapy.
9. Subjects already taking Mg or Vit-D supplements since preceding one month.
10. Subjects who have a recent or currently known history of alcohol or drug abuse.
11. Subjects with a current or past history of malignancy (any history of malignancy in the past five years).
12. Subjects suffering from major systemic diseases requiring long-term pharmacological treatment (e.g., rheumatoid arthritis, psychological, neurological, endocrine disorders, etc.).
13. Subjects who have completed their participation in any other clinical trial within the last three months.
14. Any other condition that the investigator believes may jeopardize the results of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Change in the dose of OHA(s) over a period of three months. Mean change from baseline in the dose of OHA(s) at the end of the study will be estimated.
b. Mean percent change from baseline in Fasting and Postprandial plasma glucose levels at the end of the study. Fasting and Postprandial plasma glucose levels will be estimated to assess the effect of Mg + Vit-D supplements on the serum glucose levels of the participants over study periods. |
Day 3 to Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Mean percent change in Glycosylated Hemoglobin (HbA1c) over a period of three months. Mean change from baseline in HbA1c % at the end of the study will be estimated.
b. Mean change in serum insulin levels over a period of three months.
c. Mean change on Homeostasis Model Assessment-insulin resistance (HOMA-IR) from baseline to end of the study.
d. Change in the SF-36 (RAND) Health Survey scores that measures eight multi-item dimensions of health from baseline to end of the study.
e. Change in the Diabetes Symptoms Checklist (DSC) score from baseline to end of the study (day 90).
f. Change from baseline to end of the study in waist circumference, body weight, BMI. Estimated mean change from baseline to end of the study in waist circumference, body weight, BMI will be evaluated.
g. Change in serum levels of Mg, Vit-D from baseline to end of the study.
h. Assessment of the number of treatment-emergent adverse events (AEs) during the on-treatment observation period. |
Day 3 to Day 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/04/2023 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total of 100 evaluable subjects are planned
to enrol in this study, i.e., 50 subjects each treatment group. Recruitment and
treatment of subjects is expected to be performed in 2 study centers. Each patient will receive 90 days of treatment. The treatment assignment will be as follows: Placebo Group (Arm 1, n = 50): Placebo intervention (1510-1560 mg) + Standard antidiabetic drug(s), Study Group (Arm 2, n = 50): Mg (250 mg) + Vit-D (600IU) supplement (1510-1560 mg) + Standard antidiabetic drug(s)
Change in the dose of
OHA(s) over a period of three months [from baseline (Visit 2, day 3) to the end
of the study (Visit 4, day 90)]. The mean change from baseline in the dose of
OHA(s) at the end of the study will be estimated. FBS and PPBS levels will be estimated
to assess the effect of Mg + Vit-D supplements on the serum glucose
levels of the participants over the study periods. The
mean percent change in glycosylated haemoglobin (HbA1c) over a period of three
months [from baseline (Visit 2, day 3) to the end of the study (Visit 4, day
90)]. The mean change from baseline in HbA1c% at the end of the study will be
estimated. The
mean change in serum insulin levels over a period of three months [from
baseline (Visit 2, day 3) to the end of the study (Visit 4, day 90)]. The
mean change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) from
baseline to the end of the study (day 90). Change
in the SF-36 (RAND) Health Survey scores, which measure eight multi-item
dimensions of health from baseline to the end of the study (day 90). Change
in the Diabetes Symptoms Checklist (DSC) score from baseline to the end of the
study (day 90). Change
from baseline to the end of the study in waist circumference, body weight, and
Body Mass Index (BMI). An estimated mean change from baseline to the end of the
study in waist circumference, body weight, and BMI will be evaluated. Change
in serum levels of Mg and Vit-D from baseline to the end of the study. Assessment
of the number of treatment-emergent adverse events (AEs) during the
on-treatment observation period (from baseline to the end of the study). Mg
+ Vit-D or matching placebo tablets will be administered orally once daily
after breakfast for 90 days (3 months).
|