Effects of delta-tocotrienol, resveratrol and vitamin D supplementation mixture on biochemical markers in diabetic patients

Synergistic Effects of delta-Tocotrienol, Resveratrol and Vitamin D Supplementation on Modulation of Biochemical Markers, Cytokines and miRNAs in patients of type 2 diabetes mellitus

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2018/019

Enrollment

Unknown

Registered

2018-06-21

Start date

2018-07-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Type 2 Diabetes mellitus

Interventions

Study will be conducted at Armed forces Institutes of Pathology (AFIP), National University of Medical Sciences Rawalpindi, Pakistan. The diabetic patients after screening will be assigned to one of

Group B resveratrol (200mg/day)

Group C vitamin D (2500 IU/day)

Group D combination preparation of tocotrienol, resveratrol & vitamin D (250mg+150mg+ 2500 IU per day) and Group E Placebo-(400mg, cellulose) by oral route for 24 weeks Details of each allocation ar

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pakistani male and female patients 18-70 years of age. 2. Patients of diabetes mellitus type 2 having HbA1C 7-12 % 3. Taking oral hypoglycemic agent for at least one year. 4. Duration of diabetes > 5 years

Exclusion criteria

Exclusion criteria: 1. Acute illness 2. Chronic illness including chronic liver disease, Seropositive for HIV, Hepatitis B or Hepatitis C 3. Chronic kidney diseases 4. Uncontrolled hypertension. SBP of >180 mmHg and DBP >110 mmHg 5. Thyroid disorders (TSH 5.5 µIU/mL) or thyroid malignancy 6. BMI more than 35 kg/m2 7. Medical history/clinical evidence of familial hyperlipidemic disorder. 8. Pregnant or lactating women 9. Taking insulin, statins, anti-inflammatory drugs, vitamin E and vitamin D regularly or in the last 4 weeks 10. Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
To determine the improvement in the glycemic control, reduction of oxidative stress and inflammation in the patients of type II diabetes mellitus by measuring following biochemical markers: 1. Mean reduction from baseline in glycosylated hemoglobin (HbA1c) at 24 weeks 2. Mean reduction from baseline in Serum high sensitivity C reactive protein (hsCRP) at 24 weeks 3. Mean reduction from baseline in Serum malondialdehyde (MDA) at 24 weeks [From baseline to 24 weeks of treatment within all groups]	—

Measure

Time frame

To determine the improvement in the glycemic control, reduction of oxidative stress and inflammation in the patients of type II diabetes mellitus by measuring following biochemical markers: 1. Mean reduction from baseline in glycosylated hemoglobin (HbA1c) at 24 weeks 2. Mean reduction from baseline in Serum high sensitivity C reactive protein (hsCRP) at 24 weeks 3. Mean reduction from baseline in Serum malondialdehyde (MDA) at 24 weeks [From baseline to 24 weeks of treatment within all groups]

—

Secondary

Measure	Time frame
Mean change in insulin resistance as measured by HOMA-IR 2. Mean change in microalbuminuria 3. Mean change in lipid profile 4. Mean change in serum creatinine 5. Mean change in cytokines [TNF-alpha (tumour necrosis factor alpha), interleukin (IL)-6, IL-10, IL-12, TGF-ß (Transforming growth factor-beta), Vascular endothelial growth factor (VEGF), Intercellular Adhesion Molecule (ICAM), Vascular cell adhesion molecule (VCAM) 6. Mean change in circulatory mitochondrial RNA (miRNA): miRNA-21, miRNA-34a, miRNA-126, miRNA-132, miRNA-148, mi-RNA 217, miRNA-375 [From baseline to 24 weeks of treatment within all groups]	—

Measure

Time frame

Mean change in insulin resistance as measured by HOMA-IR 2. Mean change in microalbuminuria 3. Mean change in lipid profile 4. Mean change in serum creatinine 5. Mean change in cytokines [TNF-alpha (tumour necrosis factor alpha), interleukin (IL)-6, IL-10, IL-12, TGF-ß (Transforming growth factor-beta), Vascular endothelial growth factor (VEGF), Intercellular Adhesion Molecule (ICAM), Vascular cell adhesion molecule (VCAM) 6. Mean change in circulatory mitochondrial RNA (miRNA): miRNA-21, miRNA-34a, miRNA-126, miRNA-132, miRNA-148, mi-RNA 217, miRNA-375 [From baseline to 24 weeks of treatment within all groups]

—

Countries

Pakistan

Contacts

Public ContactDr. Dilshad Ahmed Khan

Professor of Pathology

dakhan@cpsp.edu.pk0519270676

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026