Role of Vitamin D in Androgenetic Alopecia

Alopecia, Androgenetic Clinical Trial

Official title:

Role of Vitamin D in Androgenetic Alopecia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03154528
• Other study ID #: MAGA2017
• Status: Not yet recruiting
• Start date: March 30, 2019
• Est. completion date: December 12, 2019

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: Eman Mohamed, MD
• Phone: 00201005298992
• Email: e_riad[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 12, 2019
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia, Androgenetic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (14)

Amor KT, Rashid RM, Mirmirani P. Does D matter? The role of vitamin D in hair disorders and hair follicle cycling. Dermatol Online J. 2010 Feb 15;16(2):3. Review. — View Citation

Arnson Y, Amital H, Shoenfeld Y. Vitamin D and autoimmunity: new aetiological and therapeutic considerations. Ann Rheum Dis. 2007 Sep;66(9):1137-42. Epub 2007 Jun 8. Review. — View Citation

Bakry OA, El Farargy SM, El Shafiee MK, Soliman A. Serum Vitamin D in patients with alopecia areata. Indian Dermatol Online J. 2016 Sep-Oct;7(5):371-377. — View Citation

Banihashemi M, Nahidi Y, Meibodi NT, Jarahi L, Dolatkhah M. Serum Vitamin D3 Level in Patients with Female Pattern Hair Loss. Int J Trichology. 2016 Jul-Sep;8(3):116-20. doi: 10.4103/0974-7753.188965. — View Citation

Bikle DD. Vitamin D metabolism and function in the skin. Mol Cell Endocrinol. 2011 Dec 5;347(1-2):80-9. doi: 10.1016/j.mce.2011.05.017. Epub 2011 Jun 1. Review. — View Citation

Bolland MJ, Ames RW, Grey AB, Horne AM, Mason BH, Gamble GD, Reid IR. Does degree of baldness influence vitamin D status? Med J Aust. 2008 Dec 1-15;189(11-12):674-5. — View Citation

Errichetti E, Stinco G. Dermoscopy in General Dermatology: A Practical Overview. Dermatol Ther (Heidelb). 2016 Dec;6(4):471-507. Epub 2016 Sep 9. Review. — View Citation

Gupta M, Mysore V. Classifications of Patterned Hair Loss: A Review. J Cutan Aesthet Surg. 2016 Jan-Mar;9(1):3-12. doi: 10.4103/0974-2077.178536. Review. — View Citation

Kaliyadan F, Nambiar A, Vijayaraghavan S. Androgenetic alopecia: an update. Indian J Dermatol Venereol Leprol. 2013 Sep-Oct;79(5):613-25. doi: 10.4103/0378-6323.116730. Review. — View Citation

Malloy PJ, Feldman D. The role of vitamin D receptor mutations in the development of alopecia. Mol Cell Endocrinol. 2011 Dec 5;347(1-2):90-6. doi: 10.1016/j.mce.2011.05.045. Epub 2011 Jun 13. Review. — View Citation

Orme S, Cullen DR, Messenger AG. Diffuse female hair loss: are androgens necessary? Br J Dermatol. 1999 Sep;141(3):521-3. — View Citation

Rasheed H, Mahgoub D, Hegazy R, El-Komy M, Abdel Hay R, Hamid MA, Hamdy E. Serum ferritin and vitamin d in female hair loss: do they play a role? Skin Pharmacol Physiol. 2013;26(2):101-7. doi: 10.1159/000346698. Epub 2013 Feb 20. — View Citation

Varothai S, Bergfeld WF. Androgenetic alopecia: an evidence-based treatment update. Am J Clin Dermatol. 2014 Jul;15(3):217-30. doi: 10.1007/s40257-014-0077-5. Review. — View Citation

Vujovic A, Del Marmol V. The female pattern hair loss: review of etiopathogenesis and diagnosis. Biomed Res Int. 2014;2014:767628. doi: 10.1155/2014/767628. Epub 2014 Apr 9. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Vitamin D level	Laboratory test	1 year