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IRCT20251125068106N1 IRCT 2025-12-06 Birjand University of Medical Sciences Investigating the effect of vitamin C supplementation on total salivary antioxidant capacity in patients with type 2 diabetes: A randomized controlled trial Investigating the effect of vitamin C supplementation on total salivary antioxidant capacity in patients with type 2 diabetes: A randomized controlled trial 2025-12-10 anticipated 80 Recruiting https://irct.ir/trial/87792 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will be randomly allocated to the intervention (A) and control (B) groups using block randomization with a block size of 4. The six possible arrangements for blocks containing two A and two B assignments are: 1. AABB, 2. ABAB, 3. ABBA, 4. BBAA, 5. BABA, 6. BAAB. Using the RANDBETWEEN(1,6) function in Excel, 20 blocks will be randomly selected to generate the allocation sequence. Participants will then be assigned to the intervention or control group in a 1:1 ratio according to this sequence. An independent person not involved in data collection will perform the randomization. To ensure allocation concealment, the sequence will be placed in sequentially numbered, sealed, opaque envelopes. These envelopes will be opened only after a participant is enrolled, at which point the participant will be assigned to the corresponding group, Blinding description: The individuals responsible for collecting saliva samples and performing the laboratory assay of total antioxidant capacity (TAC) will not be aware of the group assignment. Furthermore, the statistical analyst will only work with the group codes and will not have access to the intervention or control status of the samples. N/A Type 2 diabetes. Intervention 1: Intervention group: Patients with type 2 diabetes who will receive one tablet containing 1000 mg of vitamin C (ascorbic acid) daily for 4 consecutive weeks. These tablets are for oral administration, preferably taken at noon with a meal. Supplement brand and manufacturer: Eurovital brand, Hekimane Teb Kär company. Intervention 2: Control group: Patients with type 2 diabetes who will not receive vitamin C supplements. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public Sajjad Labbafi Esfahrood
Birjand Dental School, Corner of Pasdaran 3, Pasdaran Blvd.
Birjand Iran (Islamic Republic of) 1713643135 +98 56 3238 1700 sajjad.L@bums.ac.ir Birjand University of Medical Sciences scientific Dr. Parvin Parvaie
Birjand Dental School, Corner of Pasdaran 3, Pasdaran Blvd.
Birjand Iran (Islamic Republic of) 1713643135 +98 56 3238 1700 parvin.parvaie@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Age between 30 and 65 years Definitive diagnosis of Type 2 Diabetes by a specialist physician (based on medical records or treatment history) according to the guidelines: Fasting Blood Sugar (FBS) greater than 126 mg/dL, or HbA1c greater than 6.5%. Stability of the diabetes control medication regimen within the past month Ability to cooperate in saliva sampling Written informed consent to participate in the study 30 years 65 years Both Diagnosis of type 1 diabetes Use of antioxidant supplements (such as vitamins E, C, A, or folic acid) and medicated or antioxidant mouthwashes within the past month Presence of other chronic systemic diseases requiring long-term medication (such as kidney or liver diseases, or malignancies) Presence of severe diabetes complications (such as advanced retinopathy, neuropathy, or nephropathy) Regular abuse of alcohol or tobacco Presence of salivary gland diseases or conditions impairing salivary secretion, and active clinical symptoms of oral diseases (such as periodontitis, gingivitis, or mucosal lesions) Missed supplement intake more than twice a week Unwillingness to continue participation in the study E08 Diabetes mellitus due to underlying condition Treatment - Drugs N/A Intervention group: Patients with type 2 diabetes who will receive one tablet containing 1000 mg of vitamin C (ascorbic acid) daily for 4 consecutive weeks. These tablets are for oral administration, preferably taken at noon with a meal. Supplement brand and manufacturer: Eurovital brand, Hekimane Teb Kär company. Control group: Patients with type 2 diabetes who will not receive vitamin C supplements. Total antioxidant capacity of saliva. Timepoint: Before the start of the intervention and after the end of the intervention (4 weeks later). Method of measurement: The total antioxidant capacity of saliva will be measured using the FRAP (Ferric Reducing Antioxidant Power) method from Kavosh Aryan Azma Company. This method is based on the reduction of Fe³⁺ (ferric) ions to Fe²⁺ (ferrous) ions in the presence of the TPTZ (Triypridyl-S-Triazine) reagent, leading to the formation of a blue-colored Fe²⁺–TPTZ complex with absorbance at a wavelength of 593 nm. The color intensity is measured by a spectrophotometer and represents the antioxidant capacity of the sample. Birjand University of Medical Sciences Approved 2025-11-19 Ethics Committee in Research, Birjand University of Medical Sciences Central Administration, Birjand University of Medical Sciences Ghaffari Street Birjand South Khorasan ,Iran Birjand South Khorasan Iran (Islamic Republic of)