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Role of Vitamin D in Androgenetic Alopecia

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ClinicalTrials.gov Identifier: NCT03154528
Recruitment Status : Not yet recruiting
First Posted : May 16, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Miral Hassan, Assiut University

Brief Summary:
Androgenetic alopecia is a common form of diffuse hair loss in both men and women,It primarily affects the top and front of the scalp with different clinical presentations and there are numerous classification systems for grading purposes.

Condition or disease Intervention/treatment
Alopecia, Androgenetic Diagnostic Test: serum vitamin D level by ELISA

Detailed Description:

These systems vary from the simple systems based on recession of the hairline to more advanced multifactorial systems based on morphological and dynamic parameters that affect the scalp and hair. Most of these systems have certain limitations. Currently, the most commonly used are Hamilton- Norwood classification system for males where there are two areas of hair loss that gradually enlarge to produce recession at the temples and thinning in the crown. These regions coalesce until the entire front, top and crown (vertex) of the scalp are bald(2 major pattern,7 grades) and the Ludwig system for females which classify the Female Pattern Hair Loss into three grades depending on the reduction in hair density over the crown and frontal scalp with retention of the frontal hairline.

Etiopathogenesis of Androgenetic Alopecia has not yet been fully elucidated. Genetic factors, hair follicle cycle abnormalities, aging process and androgen dependent process including end organ sensitivity have been all incriminated as etiological factors .

Dermoscopy has emerged as an useful tool in the diagnosis of hair loss disorder including Androgenetic Alopecia. Important features of Androgenetic Alopecia on Dermoscopy include hair shaft thickness heterogeneity, yellow dots (irregularly distributed and with a remarkable variability in size and shape), perifollicular discolouration (the peripilar sign), an increased proportion of thin and vellus hairs (>10 % of the hairs) and a large number of follicular units with only one emerging hair shaft. Thin wavy hair and honeycomb hyperpigmentation often coexist as additional, nonspecific features Vitamin D is a secosteroid hormone that plays an important role in calcium homeostasis and bone health. It has three sources: endogenous synthesis in the skin, which is induced by Ultraviolet B radiation; dietary intake; and supplementation .

Basically, Vitamin D is a modulator of both innate and adaptive immune systems through its various effects on T and B lymphocytes, dendritic cells and macrophages. There is a well-established causal connection between vitamin D deficiency and some autoimmune diseases , and possible association with some hair disorders, as it has been demonstrated that vitamin D receptors are strongly expressed in hair follicles and keratinocytes. Such an expression was found to be necessary for maintenance of the normal hair cycle. Also, it has also been shown that lack of vitamin D receptors reduces epidermal differentiation and hair follicle growth, and that an optimum concentration of Vitamin D3 is essential to delay aging and hair loss.

Several studies were done to evaluate the role of vitamin D in different hair disorders with contrasting results. Some studies revealed low serum levels of Vitamin D in women with chronic telogen effluvium,Female Pattern Hair Loss and Alopecia Areata.While, two studies showed no correlation between the extent and severity of male androgenetic alopecia with serum Vitamin D3 level.

Based on the above contrasting reports, we sought to evaluate the levels of Vitamin D in patients with androgenetic alopecia in order to establish its possible role in the etiopathogenesis and hence in the treatment of such a common and chronic hair disorder


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Role of Vitamin D in Androgenetic Alopecia
Estimated Study Start Date : March 30, 2019
Estimated Primary Completion Date : August 21, 2019
Estimated Study Completion Date : December 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
healthy control group
serum level of Vitamin D is going to be checked by ELISA in 30 healthy control volunteers
Diagnostic Test: serum vitamin D level by ELISA
The study will include 60 patients with androgenetic alopecia (30 males & 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects

case study group
serum level of Vitamin D is going to be checked by ELISA in 60 Androgenetic Alopecia patients.
Diagnostic Test: serum vitamin D level by ELISA
The study will include 60 patients with androgenetic alopecia (30 males & 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects




Primary Outcome Measures :
  1. Serum Vitamin D level [ Time Frame: 1 year ]
    Laboratory test


Biospecimen Retention:   Samples With DNA
blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study will include 60 patients with androgenetic alopecia (30 males & 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects
Criteria

Inclusion Criteria:

  • The study will include 60 patients with androgenetic alopecia (30 males & 30 females) and 30 age and sex-matched healthy volunteers.

Exclusion Criteria:

- 1-Patients with a history of topical or systemic treatment within the last month.

2-Patients with a history of concomitant skin or systemic disease. 3- Pregnant or lactating women. 4- Smokers. 5- Patients receiving phototherapy within 6 months


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): NCT03154528


Contacts
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Contact: Eman Mohamed, MD 00201005298992 e_riad@aun.edu.eg
Contact: Ayman Mohamed, MD 00201009948311 aymanderma@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Miral Taya, MD Assiut Uneversity

Publications of Results:

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Responsible Party: Miral Hassan, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03154528     History of Changes
Other Study ID Numbers: MAGA2017
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents