The Effect of Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3

NCT06142136 | Completed

• 1 other identifier: 250321-6L
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The randomized comparative study was performed on 99 outpatients with below 30 ng/ml of vitamin D. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Each participant received vitamin D3 4000 IU daily for 30 days and the vitamin D levels were measured before and after the intervention.

Conditions

Vitamin D3 Deficiency

Outcome Measures

Primary Outcomes (1)

• Changes in vitamin D level in the blood depending on the received vitamin D form.

  The study's primary outcome is to demonstrate the efficacy of sprayable microemulsion of cholecalciferol on the increase in circulating vitamin D levels over a period of 30 days.

  30 days

Study Arms (3)

Vitamin D3 sublingual sprayable microemulsion.

ACTIVE COMPARATOR

Total participants: 34 participants Duration: 30 days.

Dietary Supplement: Vitamin D substitution with sublingual sprayable microemulsion.

Vitamin D3 oil droplets.

ACTIVE COMPARATOR

Total participants: 33 participants Duration: 30 days.

Dietary Supplement: Vitamin D substitution with oil droplets

Vitamin D3 capsules.

ACTIVE COMPARATOR

Total participants: 32 participants Duration: 30 days.

Dietary Supplement: Vitamin D substitution with capsules

Interventions

Vitamin D substitution with sublingual sprayable microemulsion. DIETARY_SUPPLEMENT

Participants received sublingual sprayable microemulsion of vitamin D3 4000 IU daily for 30 days.

Vitamin D3 sublingual sprayable microemulsion.

Vitamin D substitution with oil droplets DIETARY_SUPPLEMENT

Participants received oil droplets of vitamin D3 4000 IU daily for 30 days.

Vitamin D3 oil droplets.

Vitamin D substitution with capsules DIETARY_SUPPLEMENT

Participants received capsules of vitamin D3 4000 IU daily for 30 days.

Vitamin D3 capsules.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vitamin D3 level in the blood below 30 ng/ml.

You may not qualify if:

• Celiac disease, Crohn's disease, ulcerative colitis, autoimmune gastritis.
• Patients with mental health problems.
• Vitamin D level ≥ 30 ng/ml.
• Pregnant women.
• Any other illness or condition that the researcher deemed may interfere with the results.
• Patients who refuse the studies.

Sponsors & Collaborators

• Pauls Stradins Clinical University Hospital: lead

Study Sites (1)

Pauls Stradins Clinical Univeristy Hospital

Riga, LV-1002, Latvia

Location

MeSH Terms

Interventions

Capsules

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Valdis Pirags, MD, PhD

  Pauls Stradins Clinical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: March 28, 2021
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: November 21, 2023

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)