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The role of Liposomal Vitamin C in metabolic syndrome patients

A randomized, double blind, controlled, parallel clinical trial to assess the Efficacy and Safety of Liposomal vitamin C compared with Vitamin C (non liposomal) on Immunity, inflammation and metabolic markers in adult subjects with alcohol consumption, smoking and common metabolic abnormalities.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008906
Enrollment
24
Registered
2017-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Metabolic syndrome

Interventions

Intervention1: Liposomal Vitamin C: Dose: 5 ml contains 1000 mg of Vitamin C, Route: Oral administration, Frequency: 4 times X 5 ml per day Control Intervention1: Non Liposomal Vitamin C: Dose: 5 ml c

Sponsors

CureSupport
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 years of age and above 2. Metabolic abnormalities with or without alcohol consumption and/or smoking 3. Diagnosis of MetS ie. the presence of three or more criteria of the modified National Cholesterol Education Programs Adult Treatment Panel III ( NCEP ATP III: 3.1 Waist circumference 90 cm in men and 80 cm in women 3.2 Hypertriglyceridemia >= 150 mg/dl 3.3 High density lipoprotein (HDL) cholesterol 40 mg/dl in males and 50 mg/dl in females 3.4 Blood pressure >= 130/85 mm Hg 3.5 Fasting plasma glucose >= 110 mg/dl 3.6 Patients willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Acute illness within the past 2 weeks 2. Pregnancy or breastfeeding 3. Lack of compliance with the study medication (defined as not using the medication for >1 week) 4. Documented intolerability to vitamin C 5. Participation in a concomitant trial 6. Hypersensitivity to the study medication 7. Regularly used nonsteroidal anti-inflammatory drugs (naproxen and cyclooxygenase-2 inhibitors) and/or cholesterol-lowering agents (statins) 8. Suffered from systemic and inflammatory diseases that change physical or laboratory tests (arthritis, renal, thyroid, hepatic, respiratory, gout, active malignant disease) 9. Impossibility to give informed consent 10. Intake of drugs or dietary supplements 11. Previous illnesses such as heart attack, cancer or dementia 12. Addiction illness

Design outcomes

Secondary

MeasureTime frame
Fasting blood glucose, Body weight, anthropometric assessments, Systolic blood pressure, Diastolic blood pressure, Hematology and Biochemistry Quality of life using SF-36 questionnaireTimepoint: Baseline and at 8 weeks

Primary

MeasureTime frame
Immune markers assessment: IgA, IgG and IgM Inflammatory marker C-reactive protein (CRP)Timepoint: Baseline and Week 8

Countries

India

Contacts

Public ContactDivya Chandradhar

Bio Agile Therapeutics Pvt. Ltd.

pm@bioagiletherapeutics.com9620087715

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026