| CTRI Number |
CTRI/2024/10/076052 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Vitamin and Mineral levels in Brain Function and Well-being in Women Approaching Menopause |
|
Scientific Title of Study
|
Role of Micronutrient Levels on Cognitive Function and Quality of Life in Perimenopausal Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KISHAN S KULAL |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Dept Of Medical Laboratory Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09113504525 |
| Fax |
|
| Email |
kishan.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saritha Kamath U |
| Designation |
Additional Professor/Head of the Department |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Medical Laboratory Technology, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844344459 |
| Fax |
|
| Email |
saritha.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
KISHAN S KULAL |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department Of Medical Laboratory Technology, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09113504525 |
| Fax |
|
| Email |
kishan.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal, Udupi District, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal Academy of Higher Education, Manipal, Udupi District, Karnataka, India, 576104. |
| Type of Sponsor |
Research institution |
|
|
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 Shripad S Hebbar |
Kasturba Hospital and Kasturba Medical College, Manipal |
Department of Obstetrics & Gynaecology, Kasturba Hospital and Kasturba Medical College, Manipal, 576104
Udupi
KARNATAKA |
9611786463
shripad.hebbar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Perimenopausal women having irregular menstrual cycle as per STRAW criteria
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Having an irregular menstrual cycle as per STRAW criteria |
|
| ExclusionCriteria |
| Details |
Postmenopausal women.
Women who have undergone hysterectomy and/or oophorectomy, are on hormonal replacement
therapy, are using any contraceptive aids, or are diagnosed with any condition causing unnatural
cessation of menses.
Women with a history of cognitive impairment or any other brain dysfunctions.
Individuals with bleeding or clotting disorders.
Those who are taking supplementation of micronutrients.
Those who have a chronic illness (cancer, psychological, etc.).
Women reporting hearing loss.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognitive function score: MoCA score
Kannada trial test score
Verbal learning test score
Complete blood picture
Mineral profile: Iron, magnesium and zinc
Vitamin profile: vitamin B and D
Menopause-specific Quality of Life (MENQOL) score
Perceived stress scale (PSS)
Food frequency questionnaire and 24-hour recall test
Global physical activity questionnaire |
At the time of routine blood investigation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oxidative stress markers
Mitochondrial stress markers |
At the time of analysis |
|
|
Target Sample Size
|
Total Sample Size="127"
Sample Size from India="127"
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)
|
16/11/2024 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Micronutrient sufficiency is essential for maintaining normal cognitive
function. Insufficient levels of vitamin D and B and minerals such as iron, magnesium, and zinc have
been associated with cognitive decline in menopausal women. However, these factors have not been
studied extensively during the perimenopausal period, which may be critical for promoting optimal
health during menopause. Understanding the significance of these factors is crucial for developing
public health guidelines aimed at raising awareness and preventing health issues such as Alzheimer’s
disease, dementia, and stroke. Methods for estimation of micronutrients will be
optimized using standard and pilot run of 5-10 blood samples. Participants who come for routine
checkups and have routine blood investigations will be recruited after obtaining informed consent from the OBG department, KMC Manipal. Sociodemographic data, including dietary patterns and habits,
stress, and physical activity, will be collected from the participants. Quality of life will be assessed using
the MENQOL questionnaire. Cognitive assessment will be performed using the Montreal Cognitive
Assessment tool (MoCA) with the help of a Speech-language pathologist. Kannada-making and verbal learning tests will be used to assess cognitive function. Additional 4ml of blood samples will
be collected during their routine blood investigation, or leftover samples will be obtained from the lab in
charge after completing requested lab investigations by producing a patient consent form. Serum
samples will be separated from blood and stored at -20°C to analyze nutritional biomarkers. Oxidative
and mitochondrial stress markers will be assessed. |