Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
NCT ID: NCT03443765
Last Updated: 2025-04-04
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
280 participants
OBSERVATIONAL
2017-05-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with Pityriasis alba
Detection 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.
Detection 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.
Healthy participants (control group)
Detection 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.
Detection 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.
Interventions
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Detection 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.
Detection 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.
Eligibility Criteria
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Inclusion Criteria
* Healthy individuals (control group)
Exclusion Criteria
* 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.
5 Years
14 Years
ALL
Yes
Sponsors
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Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
OTHER_GOV
Responsible Party
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Svetlana Osipova, MD, PhD, DS
Professor
Principal Investigators
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Svetlana Osipova, MD, PhD, DS
Role: PRINCIPAL_INVESTIGATOR
research institute of epidemiology, microbiology and infectious diseases
Locations
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Research institute of epidemiology, microbiology and infectious diseases
Tashkent, Uchtepa, Uzbekistan
Countries
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References
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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.
Other Identifiers
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Project #002
Identifier Type: -
Identifier Source: org_study_id
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