Comparison of serum levels of 25-hydrovitamin D after taking oral or sublingual vitamin D in medical students with insufficient serum vitamin D

Comparison of the efficacy of oral versus sublingual vitamin D supplementation on serum 25-hydroxyvitamin D levels in medical students with vitamin D deficiency

A phase 3, randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted on 60 patients. Randomization will be performed using R software.

This study is a double-blind randomized clinical trial with parallel groups, conducted on 60 male medical students at Zahedan University of Medical Sciences with vitamin D levels below 30 ng/mL. Participants will be randomly allocated into two equal groups to receive either oral or sublingual vitamin D supplementation at a dose of 50,000 units weekly for 8 weeks. Primary outcomes include changes in serum levels of 25-hydroxyvitamin D, calcium, phosphorus, and parathyroid hormone at predefined time points. Data will be analyzed and compared using statistical software.

Inclusion Criteria :Male medical students at Zahedan University of Medical Sciences-Serum 25-hydroxyvitamin D level below 30 ng/mL-Age between 18 and 40 years-Willingness to participate and provide signed informed consent- No intake of vitamin D or calcium supplements within the past 3 months. Exclusion Criteria : Chronic renal, hepatic, or gastrointestinal diseases -Use of medications affecting vitamin D metabolism -History of hypercalcemia or kidney stones- Allergy to vitamin D or any components of the supplements.

The first intervention group will receive 50,000 IU of vitamin D supplement orally on a weekly basis.The second intervention group will receive the same dosage administered sublingually each week. Both groups will follow this treatment regimen for 8 weeks and undergo periodic monitoring.

Change in serum 25-hydroxyvitamin D levels

Eligible participants who meet the inclusion criteria will be randomly assigned to one of the two intervention groups using a blocked randomization method, generated by random number software. The allocation sequence will be prepared by an independent colleague not involved in the screening or intervention process and will be concealed in sequentially numbered, opaque, sealed envelopes. The principal investigator will open the corresponding envelope only after confirming the participant's eligibility and assigning them a study ID, thereby revealing the assigned intervention (oral or sublingual supplement). This procedure ensures that both the participants and the investigating researcher are blinded to the group assignment during the allocation process.

Based on whether the patient's visit invoice number is even or odd, the patient is assigned to either group A or B, and one of the two formulations (oral or sublingual) at a dose of 50,000 units is administered by the clinical caregiver. The patient has no information about the treatments received by others. The researcher, outcome assessor, and data analyst are only aware of the findings from groups A and B and have no knowledge of which drug formulation was administered in each group.

Only the portion of data relevant to the main topic is displayed.

Access period begins 6 months after the publication of results.

Will only be accessible to researchers affiliated with academic and scientific institutions.

There are no special requirements

Please refer to Dr. Mahperi Zafar Zaman, Internal Medicine Department, Imam Ali Ibn Abi Talib Hospital, Zahedan.

Requests will be reviewed via email at dr.zafarzaman@zaums.ac.ir and responded to in the shortest possible time