Vitamin D Supplementation in Acne

• Sponsor: HITEC-Institute of Medical Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06141330
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 19.4

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:

• To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.

Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.

Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Dietary Supplement: D Max Drops; Drug: Azithromycin 250 milligram Oral Capsule; Drug: Adapalene	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Vitamin D Supplementation in Combination With Azithromycin and Topical Retinoid for Acne: A Randomized Controlled Trial
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D	Dietary Supplement: D Max Drops; Vitamin D; Drug: Azithromycin 250 milligram Oral Capsule; Anti Biotic; Drug: Adapalene; Retinoid
Active Comparator: Placebo	Drug: Azithromycin 250 milligram Oral Capsule; Anti Biotic; Drug: Adapalene; Retinoid

Outcome Measures

Primary Outcome Measures

1. Efficacious [2 months]

   Improvement in Global Acne Grading System Score from baseline to after 2 months of treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Individuals aged between 13 and 40 years with diagnoses of Acne vulgaris are included.

Exclusion Criteria:

• Individuals currently undergoing treatment for polycystic ovary syndrome (PCOs)

• Those with obesity

• Individuals employing vitamin supplementation

• Those under the influence of topical or systemic steroids and acne treatment in the last 2 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hitec-Ims	Islamabad	Punjab	Pakistan	47080

Sponsors and Collaborators

• HITEC-Institute of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aqsa Naheed, Professor, MBBS, FCPS, HITEC-Institute of Medical Sciences
• ClinicalTrials.gov Identifier: NCT06141330
• Other Study ID Numbers: Vit-D
• First Posted: Nov 21, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Aqsa Naheed, Professor, MBBS, FCPS, HITEC-Institute of Medical Sciences: AcneVulgaris; Vitamin D
• Additional relevant MeSH terms: Acne Vulgaris; Azithromycin; Adapalene

Study Results

No Results Posted as of Nov 21, 2023