Efficacy of Vitamin C Supplementation on Malondialdehid Levels and Disease Activity in SLE Patients

Universitas Sriwijaya

Status: Completed

Conditions: Systemic Lupus Erythematosus (SLE)

Treatments: Dietary Supplement: Vitamin C; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07083622

DP0403DXVIII0608ETIK2392024

Details and patient eligibility

About

The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards malondialdehid levels and disease activity with the MEX-SLEDAI score in Systemic Lupus Erythematosus (SLE) patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited ≥ 18 years old SLE patients, with mild to moderate disease activity and did not consumed vitamin C 1 week prior to the trial study. Participants were randomized into two groups receiving vitamin C supplementation, or placebo. Malondialdehid levels and MEX-SLEDAI score were evaluated at the beginning and at the end of the 8 week trial for analysis.

Full description

This research is a double blind randomized controlled trial study. The study subjects were 38 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received vitamin C supplementation twice daily for 8 weeks and the group that received placebo. Serum malondialdehid levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. All patients diagnosed with mild to moderate systemic lupus erythematosus (SLE).
2. Patients aged over 18 years.
3. Willing to participate in the study by signing an informed consent form.

Exclusion Criteria

1. Pregnant or breastfeeding patients.
2. Patients currently taking vitamin C supplementation within the past 3 days.
3. Patients with other immune-related disorders, either autoimmune or immunocompromised conditions, such as Human Immunodeficiency Virus (HIV) infection.
4. Patients with comorbid diseases.
5. Patients diagnosed with severe SLE or those who have achieved remission.
6. Patients with hemochromatosis.
7. Patients with a history of kidney stones.

Drop-Out Criteria

1. Death before the completion of the study.
2. Patients who stop taking the study medication for more than 3 weeks.
3. Occurrence of severe side effects or worsening of the disease.
4. Hospitalization or symptom worsening during the intervention period.
5. Loss to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

Vitamin C

Experimental group

Description:

The patients were given a tablet containing Vitamin C 500 mg twice a day

Treatment:

Dietary Supplement: Vitamin C

Placebo

Placebo Comparator group

Description:

The patients were given a placebo capsule with a similar color, shape, size and taste twice a day

Treatment:

Dietary Supplement: Placebo