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CTRI Number  CTRI/2017/08/009254 [Registered on: 03/08/2017] Trial Registered Retrospectively
Last Modified On: 11/07/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessing the levels of nutrients like Biotin and copper in blood and hair of women with hair loss 
Scientific Title of Study   Quantification of levels of biotin and copper in serum and hair samples of women with chronic telogen effluvium 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Malathi  
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Dr. M.Malathi, Assistant Professsor, Department of Dermatology and STD, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Puducherry – 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  07373842888  
Fax    
Email  mmalathi.dr@live.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Malathi  
Designation  Assistant Professsor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Dr. M.Malathi, Assistant Professsor, Department of Dermatology and STD, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Puducherry – 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  07373842888  
Fax    
Email  mmalathi.dr@live.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Malathi  
Designation  Assistant Professsor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Dr. M.Malathi, Assistant Professsor, Department of Dermatology and STD, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Puducherry – 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  07373842888  
Fax    
Email  mmalathi.dr@live.com  
 
Source of Monetary or Material Support  
IADVL Hair and Skin Research Grant-2016 Dr. Shyamanta Barua, Honorary Secretary General, Indian Association of Dermatologists, Venereologists & Leprologists, IADVL National Headquarters, 4772-73 Pvt No.,T-3 & T-4, 3rd Floor, 23 Bharat Ram Road, Darya Ganj, New Delhi-110002.  
 
Primary Sponsor  
Name  Indian Association of Dermatologists Venereologists and Leprologists 
Address  Dr. Shyamanta Barua, Honorary Secretary General, Indian Association of Dermatologists, Venereologists & Leprologists, IADVL National Headquarters, 4772-73 Pvt No.,T-3 & T-4, 3rd Floor, 23 Bharat Ram Road, Darya Ganj, New Delhi-110002.  
Type of Sponsor  Other [Indian Association of Dermatologists Venereologists and Leprologists] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr MMalathi  JIPMER  Department of Dermatology and STD, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Puducherry – 605006
Pondicherry
PONDICHERRY 
7373842888

mmalathi.dr@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Cases women aged 18-45 years with diffuse hair loss lasting for more than 6 months diagnosed as chronic telogen effluvium Controls women with no hair loss, (1) ICD-10 Condition: L650||Telogen effluvium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Cases:
• Consecutive consenting women aged 18-45 years presenting to the dermatology OPD with diffuse hair loss lasting for more than 6 months diagnosed as chronic telogen effluvium based on modified hair wash test and trichoscopy
Controls:
• Consenting women with no hair loss attending the dermatology OPD
 
 
ExclusionCriteria 
Details  Cases and Controls:
• Lactating women
• Post-menopausal women
• Prescription drugs known to affect the hair growth within the last six months
• Known systemic causes of hair loss (symptomatic anemia with Hb < 10gm/dl, overt hypo or hyperthyroidism on treatment, known diabetics and hypertensives on treatment, hepatic and renal diseases, connective tissue diseases, malignancies, tuberculosis)
• Chronic drug intake
• Inflammatory dermatoses involving scalp and hair – psoriasis, lichen planus, discoid lupus erythematosus
• History of hair dye application and cosmetic hair treatments like straightening, ironing, perming in the last 6 months.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Levels of biotin and copper in serum and hair samples  at the end of the stu












one year.

 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/10/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   No publication yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Women presenting with diffuse hair loss is a common challenging problem encountered by the dermatologists. The most common cause is telogen effluvium which is often triggered by endocrine, nutritional or autoimmune etiologies. However, in chronic telogen effluvium (CTE) wherein the hair loss lasts for more than 6 months, the precipitant is often not identified and it is often a routine practice to supplement these patients with biotin and micronutrients like zinc, copper, iron and selenium. The rationale of supplementation is based on the observation that alopecia is one of many consequences associated with biotin, copper and zinc deficiencies. However till date there are no evidences to support deficiency of biotin or these micronutrients and there are no clinical trials to demonstrate their supplementation to be effective in hair loss (CTE).  This is also the case with iron deficiency, which is often believed to be a cause of hair loss (CTE) , wherein the literature reports are inconsistent regarding role of iron supplementation. Some nutritional supplements are, however, approved as drugs not requiring prescriptions and not reimbursable by health care insurers. In addition, it has also been reported that excessive intakes of nutritional supplements may actually cause hair loss and are not recommended in the absence of a proven deficiency.

Hence, we propose to study the levels of biotin and copper in serum and hair of women with chronic telogen effluvium in comparison to those without hair loss. If a deficiency of biotin and copper is observed in those with hair loss, we would like to estimate the cut off levels at which hair loss occurs.



 
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