| CTRI Number |
CTRI/2025/03/081543 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
healthy volunteers study to evaluvate safety of Selenium in the given Selenium formulation |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Selenium in the given Selenium formulation, L-Seleno Methionine 5000 Calcium hydrogen Phosphate Dihydrate (LSM -5000 CHPD) in normal healthy volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SSGL_CRD/129/LSMCHPD_SFTY/I/NOV/24V1.0 23Nov2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharath Raj R |
| Designation |
principal Investigator |
| Affiliation |
Mithra Multispeciality Hospital |
| Address |
Mithra Multi Speciality Hospital
Neeladri No 6 SR Layout Kyalasanahalli Village Jigani Town
Bommasandra Jigani Link Rd Electronics City Phase
Bengaluru Karnataka 560105
Bangalore
KARNATAKA
560105
India |
| Phone |
9686343580 |
| Fax |
|
| Email |
bharathraj.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish G |
| Designation |
VicePresident |
| Affiliation |
Sami-Sabinsa Group Limited |
| Address |
191 & 19 2 I Main II Phase Peenya Industrial Area Bangalore560058
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560058
India |
| Phone |
9900128263 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Satish G |
| Designation |
VicePresident |
| Affiliation |
Sami-Sabinsa Group Limited |
| Address |
191 & 19 2 I Main II Phase Peenya Industrial Area Bangalore560058
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560058
India |
| Phone |
9900128263 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
|
Source of Monetary or Material Support
|
| Sami Sabinsa Group Limited 19 1 & 19 2 I Main II Phase Peenya Industrial Area, Bangalore,
Karnataka. 560058. |
|
|
Primary Sponsor
|
| Name |
Sami-Sabinsa Group Limited |
| Address |
Sami-Sabinsa Group Limited 19 1 & 19 2 I Main II Phase Peenya Industrial Area Bangalore,
Karnataka. 560058 |
| Type of Sponsor |
Other [[Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements]] |
|
|
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 Udayakumar N |
Abiramm Hospital |
Room No 3 Department of Radiology Hosur main road near govt hospital Hosaroad above Vinodhadiagnostics Bengaluru 5601000
hosa road above vinodha diagnostics
Bangalore karnataka 560100
Bangalore
KARNATAKA |
9742052111
tvnudayakumar1@gmail.com |
| Dr Bharath RajR |
Mithra Multi-Speciality Hospital, |
Room No 3 department of Orthopedic Neeladri No 6 SR Layout Kyalasanahalli Village Jigani Town
Bommasandra Jigani Link Rd, Electronics City Phase 1,
Bengaluru, Karnataka 560105
Bangalore
KARNATAKA |
9686343580
bharathraj.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sri Durgamba Independent Ethics Committee, |
Approved |
| Sri Durgamba Independent Ethics Committee, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
safety study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo [Calcium hydrogen PhosphateDihydrate] |
Dose: 240 mg
Dosage form: Capsule
Frequency: Once a day after breakfast for30days
Route of administration: Oral
|
| Intervention |
Selenium formulation [L-Seleno Methionine 5000 Calcium hydrogen Phosphate Dihydrate qs (LSM -5000 CHPD)] |
Dose: 100 mcg plus qs CHPD
Dosage form: Capsule
Frequency: Once a day after Breakfastfor 30days
Route of administration: Oral
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female participants whose age above18 andbelow 49 years and having Body Mass Index BMI in the range of 18 to 25 kgm2
2. Participants must provide written and signed informed consent and comply with the requirements of the study.
3. Must be able to swallow oral medications for 30 days on a daily basis and comply with the study requirements as per the protocol.
4. In good health conditions as determined by study investigator through medical history, physical examination, vital signs, and laboratory tests.
5. Participants must consume Investigational Products only during the study. He or She must refrain from consuming any prebiotic, postbiotic, vitamins, minerals & any other supplements during the study.
6. Female participant of childbearing potential must use an approved method of contraception and must be willing to continue its use throughout the study duration or female participant of non childbearing potential
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women and having the intention to be pregnant within the next six months
2.Drinking alcohol and smoking in the last three months.
3.Consumption of any other medications
4. History or presence of hepatic or gastrointestinal illnesses or other conditions that may interfere with the drugs absorption distribution excretion or metabolism.
prescription or over the counter including vitamins and minerals during the study.
5. History of renal pulmonary epileptic hematologic cardiovascular neurological or psychiatric illness and immunodeficiency diseases.
6.Blood Pressure 90/60mmHg and 140100mmHg.
7. Glycosylated Hemoglobin HbA1c 4 and 6.5% and Fasting Blood Glucose 70 and 110 mgdL
8. Lipid profile: Total Cholesterol 240 mgdL LDL Cholesterol LDLC 150 mgdL Triglycerides 200 mgdL
9. Thyroid TSH 0.35 & 6.0 µIUmL
10. History of malignancy
11. Subject with history of drug abuse or significant alcoholism.
12. Donation or loss of 450 mL or more of blood within the 3 months prior to ScreeningBaseline.
13. Known case on any form infections.
14.Subjects with concurrent serious hepatic disorder defined as Aspartate Amino Transferase AST andor Alanine Amino Transferase ALT Alkaline Phosphatase ALP1.5 times upper normal limitTotal Bilirubin 1.2 or Renal Disorders defined as S. Creatinine 1.2mg/dL & EGFR 60 or less
15. Subject has participated in any clinical trial within the last 3 months.
16.Signs of Selenium toxicity like
1 Gastrointestinal Symptoms Nausea, vomiting, and diarrhea.
2 Neurological Symptoms Fatigue, irritability and peripheral neuropathy tingling or numbness.
3 Dermatological Symptoms Hair loss (alopecia brittle nails and dermatitis.
4 Respiratory SymptomsGarliclike odor in breath due to volatile selenium compounds.
5 Cardiovascular EffectsTachycardia or arrhythmia.
6 Liver and Kidney Dysfunction Elevated liver enzymes or impaired renal function.
17. Signs of Selenium deficiency like
1 Weak Immune Function Increased susceptibility to infections or a history of frequent illnesses and lab results during screening.
2 Muscle Weakness or Pain Myopathy or general muscle discomfort.
3 Fatigue: Generalized fatigue or low energy levels.
4 Cardiovascular Symptoms Potential signs of heart issues, particularly cardiomyopathy or heart failure.
5 Cognitive and Mood Changes: Anxiety, depression, or mental fogginess.
6 Thyroid Dysfunction Signs of hypothyroidism fatigue, weight gain, sensitivity to cold.
18. Any other condition that the Principal Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| o To assess the safety of the given Selenium formulation based on the IP compliance, signs of selenium toxicity, incidence of any AE/SAE due to the IP |
Day1 to Day30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in Thyroid function T3 T4, TSH , Antioxidant activity (Glutathione Peroxidase) and Seleno-proteins by measuring the selenium levels (in serum and urine from the beginning till the end of the study period |
Day1 to Day30 |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| Date of Study Completion (India) |
15/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
LSM-5000 CHPD formulation in healthy volunteers through a randomized, double-blind design. The study will provide robust evidence to support the safe use of L-SeMet as a dietary supplement By demonstrating the safety and efficacy profile of the organic selenium formulation, the study hascontributed valuable insights to public health recommendations and inform strategies for preventing selenium deficiency-related health issues on a global scale.
|