| 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
|
|
|
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
|
|
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
|
|
|
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.
|