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

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ClinicalTrials.gov Identifier: NCT03443765
Recruitment Status : Active, not recruiting
First Posted : February 23, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Brief 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.


Condition or disease Intervention/treatment
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

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Group/Cohort Intervention/treatment
Patients with Pityriasis alba Diagnostic Test: 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.

Diagnostic Test: 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) Diagnostic Test: 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.

Diagnostic Test: 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.




Primary Outcome Measures :
  1. Serum 25(OH) vitamin D levels in the patients with pityriasis alba [ Time Frame: up to 24 months ]
    In this study we expect to determine a role of Vitamin D in the development and course of pityriasis alba

  2. Total serum immunoglobulin E levels in the patients with pityriasis alba [ Time Frame: up to 24 months ]
    In this study we expect to determine a role of immunoglobulin E in the development and course of pityriasis alba



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   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.

Criteria

Inclusion Criteria:

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443765


Locations
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Uzbekistan
Research institute of epidemiology, microbiology and infectious diseases
Tashkent, Uchtepa, Uzbekistan, 100133
Sponsors and Collaborators
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Additional Information:

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Responsible Party: Svetlana Osipova, MD, PhD, DS, Professor, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
ClinicalTrials.gov Identifier: NCT03443765     History of Changes
Other Study ID Numbers: Project #002
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pityriasis
Pityriasis Rosea
Dandruff
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Scalp Dermatoses
Vitamin D
Ergocalciferols
Vitamins
Immunoglobulins
Antibodies
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Immunologic Factors