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IRCT20210519051348N5 IRCT 2026-09-29 Islamic Azad University Evaluation of the effect of adding a Vitamin C supplement to levothyroxine compared to levothyroxine alone in patients with primary hypothyroidism Evaluation of the effect of adding vitamin C supplementation to Levothyroxine compared with Levothyroxine alone on laboratory parameters and clinical symptoms in patients with primary hypothyroidism: A randomized, placebo-controlled pilot clinical trial 2026-09-23 anticipated 40 Recruiting https://irct.ir/trial/93495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to either the intervention group (Vitamin C) or the control group (placebo) in a 1:1 ratio. A fixed-block randomization method (block size of 2) will be employed to ensure an even distribution of participants across the treatment groups throughout the enrollment period. The randomization sequence will be generated by an independent third party—who is not involved in participant assessment or data collection—using randomization software (such as Sealedenvelope.com). The allocation sequence within each block will be fully randomized, and the list contents will remain concealed from the research team until the study concludes (allocation concealment). Following the acquisition of informed consent and confirmation of eligibility criteria, participants will be assigned to one of two groups based on their sequential number in a coded list, in the order of their enrollment. The person responsible for allocation—unaware of the contents of the subsequent block—will determine and announce the assigned group solely based on the participant's sequential number. This process enables the control of selection bias and the maintenance of statistical balance between the groups, Blinding description: The patient, physician, researcher, and evaluator (student) will remain unaware of whether the patient has received the drug or the placebo (double-blinding). The drug (Vitamin C) and the placebo will be prepared as effervescent tablets that are identical in shape, color, size, taste, and method of administration, ensuring that participants cannot distinguish between them. The coding of the medication boxes will be performed by an independent third party not involved in the study, and the code will not be broken until the study concludes. 3 Effect of Adding Vitamin C Supplementation to Levothyroxine Compared with Levothyroxine Alone. Intervention 1: Intervention group: The pharmacological intervention consists of administering a 60 mg Vitamin C effervescent tablet daily. Participants in the intervention group will dissolve the tablet in a glass of water and consume it in the morning on an empty stomach, concurrently with their levothyroxine tablet. The 60 mg Vitamin C effervescent tablets will be produced in the university laboratory. Intervention 2: Control group: Participants in the control group will dissolve a placebo effervescent tablet (containing no Vitamin C) in a glass of water and consume it daily on an empty stomach in the morning, concurrently with their levothyroxine tablet. The placebo effervescent tablets will be produced in the university laboratory. Yes - There is a plan to make this available What will be shared: All study data will be available for sharing upon request after de-identification and anonymization of participant information, in accordance with confidentiality requirements. When: Just after the article's publication To whom: To whom data/document is available Conditions: De-identified individual data will be available to qualified researchers upon written request and ethics committee approval after publication of the main results. Data may only be used for scientific purposes; commercial use is prohibited. Where to obtain: For further information or to request access to the data, applicants may correspond via email with the Clinical Department of the Islamic Azad University (Pharmaceutical Sciences Branch) and Dr. Hashemian. Email: farshadhashemian@gmail.com How to obtain: Applicants may request access to the study data by contacting the relevant department through the provided email address or telephone number. Requests should include information regarding the applicant’s academic background, institutional affiliation, and the intended purpose of data use. Applicants will also be required to acknowledge and appropriately cite the original study in any resulting scientific work. De-identified study data will be available beginning six months after publication of the study results. Following approval of the request by the principal investigator, the data files will be provided to eligible applicants via email within approximately one week. Comments:
public Mobina Asasi
No 99, Yasaman Alley, Yakhchal St, Shariati Av
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 Mobina2003.asadi@gmail.com Islamic Azad University scientific Farshad Hashemian
No 99, Yasaman Alley, Yakhchal St, Shariati Av
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 farshadhashemian@gmail.com Islamic Azad University Iran (Islamic Republic of) Ages 18 to 65 The criteria include a diagnosis of primary hypothyroidism by a specialist, use of a fixed dose of levothyroxine for at least the past eight weeks, and suboptimal thyroid control—characterized by a TSH level exceeding the laboratory's upper limit of normal and 4.5 mIU/L—despite regular levothyroxine intake. 18 years 65 years Both Patients with renal failure, a history of recurrent kidney stones, hyperoxaluria, iron overload disorders (such as hemochromatosis or thalassemia major), or G6PD deficiency. Pregnant or breastfeeding Regular consumers of high doses of vitamin C or other antioxidants. E03.9 Hypothyroidism, unspecified Treatment - Drugs Placebo Intervention group: The pharmacological intervention consists of administering a 60 mg Vitamin C effervescent tablet daily. Participants in the intervention group will dissolve the tablet in a glass of water and consume it in the morning on an empty stomach, concurrently with their levothyroxine tablet. The 60 mg Vitamin C effervescent tablets will be produced in the university laboratory. Control group: Participants in the control group will dissolve a placebo effervescent tablet (containing no Vitamin C) in a glass of water and consume it daily on an empty stomach in the morning, concurrently with their levothyroxine tablet. The placebo effervescent tablets will be produced in the university laboratory. TSH level. Timepoint: Beginning of the study and the end of week 8. Method of measurement: ELISA method. Free T4 level. Timepoint: Beginning of the study and the end of week 8. Method of measurement: ELISA method. Clinical score for hypothyroidism based on the Zulewski questionnaire. Timepoint: Beginning of the study and the end of week 8. Method of measurement: Zulewski questionnaire. Islamic Azad University Approved 2026-06-09 REC of Islamic Azad Tehran Medical Sciences University-Pharmacy and Pharmaceutical Branches faculty No 99, Yasaman Alley, Yakhchal St, Shariati Av Tehran Tehran Iran (Islamic Republic of)