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Active, not recruitingNCT03443765Updated Apr 4, 2025

Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba

An observational study in Pityriasis Alba, sponsored by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan. Active, not recruiting at 1 site in Uzbekistan. Open to participants aged 5 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
280
Ages
5 Years to 14 Years
Sex
All
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Study summary

Pityriasis alba (PA) is a common, benign skin disorder occurring predominantly in children and adolescents. It is characterized by ill-defined hypopigmented macules and patches, round or oval in shape. They are most commonly located on the face (especially the cheeks), arms, and upper trunk; and they are more noticeable in people with darker skin types. Sun exposure accentuates the lesions. Patients and their parents are often anxious about the cosmetic appearance of the lesions. PA is not seasonal, although peeling may be worse in the winter (as a result of dry air in homes) and lesions may be more obvious in the spring and summer (as a result of sun exposure and darkening of the surrounding skin).No specific cause of PA has been identified. It is not contagious, and no infectious etiology has been reported. It is most common in individuals with a history of atopy, although it may occur in nonatopic individuals.

In the present study, we will investigate the role of serum vitamin D levels and serum total IgE levels with development and course of PA. Plasma levels of 25(OH) vitamin D and Total serum immunoglobulin E will be determined by using ELISA technique.

Read the detailed description

The prospective cohort study will be conducted on the basis of Research Institute of Epidemiology, Microbiology and Infectious Disease, Ministry of Public Health of the Republic of Uzbekistan.

Both informed and written consents will be obtained from the parents or from appropriate relative or guardian of the patients and healthy individuals of the control group.

Study participants will be included about 30 children aged 5 to 12 years with pityriasis alba. The control group will be included about 20 healthy individuals. All the participants will be residents of Uzbekistan.

Diagnosis of pityriasis alba Diagnosis of pityriasis alba will be based on the results of clinical examination. Inclusion criteria: revealing multiple round or oval-shaped hypopigmented macules or patches with indistinct margins. A weak erythema may be observed in some patches. The lesions number could varied from four to ten, 0.5 cm - 5 cm in size, and they are distributed predominantly on the face, neck, upper arms, and upper trunk.

Exclusion criteria The exclusion criteria: chronic and acute infectious diseases, endocrine diseases, congenital diseases, allergic dermatitis, bronchial asthma, allergic rhinitis and/or conjunctivitis, other skin disorders, history of using vitamin D supplements within three months ago, or use of any medication influencing endocrine parameters.

Measurement of anthropometric indices Demographic data will be obtained in the survey included age, gender, and body mass index (BMI) calculated as weight (kg)/height2 (m2).

Sample Collection and Storage Five milliliters of peripheral venous blood sample will be taken (after 8-12 hours of fasting) from each participant and will be collected into HumaTube Serum Gel - C/A for ELISA. Serum will be appropriately obtained and stored at -20°C maximum of 30 days. All blood samples will be collected during summer period.

Estimation of Vitamin D and Total Immunoglobulin E Plasma levels of 25(OH) vitamin D (DIAsource kit, Belgium) and Total serum immunoglobulin E (HUMAN kit, Germany) will be determined using ELISA technique.

Classification of Vitamin D and Total Immunoglobulin E Serum vitamin D level will be classified as reported by Holick (Holick MF. 2007). Levels of vitamin D ≤20, 21-29, ≥30-150, and >150 ng/ml will be considered as vitamin D deficiency, vitamin D insufficiency, vitamin D sufficiency and vitamin D intoxication, respectively.

Normal levels of total immunoglobulin E for children 1-6 years old - \<30 Ul/ml, 7-9 years old - \<60 Ul/ml and 10-12 years old - \<100 Ul/ml, 13-16 years old - \<150 Ul/ml.

02

Conditions studied

  • Pityriasis Alba
03

In context

Lead sponsor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The prospective cohort study will be conducted on the basis of Research Institute of Epidemiology, Microbiology and Infectious Disease, Ministry of Public Health of the Republic of Uzbekistan. All participants will be residents of Uzbekistan.

Diagnosis of pityriasis alba will be based on the results of clinical examination.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with Pityriasis alba
  • Healthy individuals (control group)

Exclusion criteria

Exclusion Criteria:

  • chronic and acute infectious diseases;
  • endocrine diseases;
  • congenital diseases;
  • allergic dermatitis;
  • bronchial asthma;
  • allergic rhinitis and/or conjunctivitis;
  • other skin disorders;
  • history of using vitamin D supplements within three months ago, or use of any medication influencing endocrine parameters.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
280 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Patients with Pityriasis alba

    Diagnostic Test: Detection of Plasma levels of 25(OH) vitamin D by ELISA technique · Diagnostic Test: Detection of Total serum immunoglobulin E by ELISA technique

  • Healthy participants (control group)

    Diagnostic Test: Detection of Plasma levels of 25(OH) vitamin D by ELISA technique · Diagnostic Test: Detection of Total serum immunoglobulin E by ELISA technique

Interventions

  • Diagnostic testDetection of Plasma levels of 25(OH) vitamin D by ELISA technique

    Five milliliters of peripheral venous blood sample will be taken (after 8-12 hours of fasting) from each participant and will be collected into HumaTube Serum Gel - C/A for ELISA. Serum will be appropriately obtained and stored at -20°C maximum of 30 days. Plasma levels of 25(OH) vitamin D will be detected by enzyme-linked immunosorbent assay (ELISA) technique.

  • Diagnostic testDetection of Total serum immunoglobulin E by ELISA technique

    Five milliliters of peripheral venous blood sample will be taken (after 8-12 hours of fasting) from each participant and will be collected into HumaTube Serum Gel - C/A for ELISA. Serum will be appropriately obtained and stored at -20°C maximum of 30 days. Total serum immunoglobulin E will be detected by enzyme-linked immunosorbent assay (ELISA) technique.

06

What researchers measure

Primary outcomes

  1. Serum 25(OH) vitamin D levels in the patients with pityriasis alba

    In this study we expect to determine a role of Vitamin D in the development and course of pityriasis alba

    Time frame: up to 24 months

  2. Total serum immunoglobulin E levels in the patients with pityriasis alba

    In this study we expect to determine a role of immunoglobulin E in the development and course of pityriasis alba

    Time frame: up to 24 months

07

Study locations

1 site
08

References and documents

Publications

  • Toychiev A, Mirzoeva M, Davis N, Islamova J, Osipova S. Pityriasis alba: Possible associations with intestinal helminths and pathogenic protozoa. Int J Clin Pract. 2020 Feb;74(2):e13441. doi: 10.1111/ijcp.13441. Epub 2019 Oct 30. PubMed 31633268 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2017 (actual). Primary completion is estimated for Dec 2025, 103 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2018
First posted
Feb 23, 2018
StartActual
May 1, 2017
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03443765
Lead sponsor
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
Responsible party
Svetlana Osipova, MD, PhD, DS (Professor, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan) — Principal investigator
First posted
Feb 23, 2018
Start date
May 1, 2017
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 4, 2025

Study contacts

Svetlana Osipova, MD, PhD, DS
principal investigator · research institute of epidemiology, microbiology and infectious diseases

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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