| CTRI Number |
CTRI/2024/11/076180 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Multivitamin Mineral Supplement Clinical trial on womens health. |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, multicenter clinical study to evaluate the effects of a
Multivitamin Mineral Supplement on womens health. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/012, Version 1.00; dated 07 June 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suchitra Pandit |
| Designation |
Senior Consultant |
| Affiliation |
Surya Hospital |
| Address |
Obstetrics & Gynecology department, S V Road, Santa Cruz, West Mumbai
Mumbai
MAHARASHTRA
400054
India |
| Phone |
9820416474 |
| Fax |
- |
| Email |
suchipan56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rumaiza Mamsa |
| Designation |
Medical services |
| Affiliation |
Meyer Organics Pvt. Ltd. |
| Address |
First floor, Medical service department , A 303 Road No 32 Wagle Estate Thane
Mumbai
MAHARASHTRA
400604
India |
| Phone |
9167846090 |
| Fax |
9162757002 |
| Email |
rumaizamamsa5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Chhabria |
| Designation |
Medical services |
| Affiliation |
Meyer Organics Pvt. Ltd. |
| Address |
First floor, Medical service department , A 303 Road No 32 Wagle Estate Thane
Mumbai
MAHARASHTRA
400604
India |
| Phone |
7066706538 |
| Fax |
9162757002 |
| Email |
vchhabria@meyer.co.in |
|
|
Source of Monetary or Material Support
|
| Meyer Organics Pvt. Ltd.
A-303, Road No. 32, Wagle Estate, Thane, Maharashtra- 400604 |
|
|
Primary Sponsor
|
| Name |
Meyer Organics Pvt. Ltd. |
| Address |
A-303, Road No. 32, Wagle Estate, Thane, Maharashtra- 400604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gorakh G Mandrupkar |
Mandrupkar Clinic |
Opposite S. T. Stand, More nagar, Islampur, Dist. Sangli 415409
Sangli
MAHARASHTRA |
9860963794
-
drmango@rediffmail.com |
| Dr Suchitra Pandit |
Surya Hospital |
S V Road, Santa Cruz, West Mumbai
Mumbai
MAHARASHTRA |
9820416474
-
suchipan56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Central Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multivitamin Mineral
Supplement (MVMS) Capsules |
One Capsule daily after dinner
once a day for 90 days(3
months) orally through mouth
along with water. |
| Comparator Agent |
Placebo capsule |
One Capsule daily after dinner
once a day for 90 days(3
months) orally through mouth
along with water. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Women of age within the range of 18 to 55 years (both
inclusive);2. Body mass index (BMI) not less than 19 and not more
than 35 kg per m 2 ; 3. Participants in normal physiological health as determined by personal medical history, clinical examination
including vital signs, and clinically acceptable results of laboratory examinations with no chronic medical conditions; 4. Participants must have a regular menstrual cycle; 5. Participants must be willing to practice at least one of the following methods of birth control:
(1)Total abstinence from sexual intercourse with someone of the
opposite sex during the study duration; (2) Sexual intercourse with a vasectomized partner; (3) Contraceptive (oral, parenteral, or
transdermal) for at least 3 consecutive months prior to and during the study duration; (4) Use of an intrauterine contraceptive device; (5) Other acceptable forms of birth control (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream); 6. Not currently taking any MVMS or similar supplements;7. Willing to comply with trial procedures and visit schedules. |
|
| ExclusionCriteria |
| Details |
1. Medical history including but not limited to the following:
cardiovascular disease, cancer, coagulopathies, current anemia,
epilepsy, thyroid disease, parathyroid diseases, diabetes, hepatitis,
brain injuries or other brain-related diseases, depression treated with
prescription medications, liver diseases, abnormal lipid metabolism,
digestive disorders (Crohns, pancreatitis, ulcerative colitis), multiple
sclerosis, muscular dystrophy, asthma or COPD;
2. Significant medical or psychiatric conditions that could interfere
with trial participation as per the judgement of the investigator;
3. Known hypersensitivity to any component of the MVMS or
placebo;
4. Participants currently taking any of the following supplements for
health maintenance or benefits: multivitamin-mineral (MVM), prenatal
vitamins, B vitamins, fish oil, krill oil, flaxseed oil, melatonin, niacin,
Ayurvedic or herbal supplements, nutraceutical supplements, fiber
supplements, glucosamine or chondroitin, sports supplements,
drinks or powders containing vitamins and minerals, meal
replacement drinks or powders with 100% or more of the Daily
Values for vitamins and minerals, probiotics, vitamin D, calcium
supplements, iron supplements, or protein powders;
5. Pregnancy or breastfeeding;
6. Any prescribed medication except for oral contraceptives (not
acceptable if oral contraceptives are used to disrupt normal or
monthly menstrual cycle) - includes recent antibiotic and or oral
corticosteroid use;
7. Past or active smokers;
8. Irregular menstrual cycles or amenorrhea;
9. Donated blood within two months prior to study entry, and must
not donate blood during the study duration;
10. Consumers of alcohol, more than 5 drinks of alcohol per week
(one drink of alcohol was considered to be 142 mL of standard wine,
340 mL of beer, 35 mL of 80-proof liquor, or 10 mL of pure alcohol);
11.Have participated in any investigational therapeutic trial within the past 1 year that the investigator feels would influence or affect the
outcome of the study;
12.Anyone incapable of adhering to the study protocol or knowing
likelihood of moving away from the study site. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in self-reported general health and
well-being assessed by a SF-36 Health Survey. |
Screening, day 45 and day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in nutrient levels of serum iron,
vitamin D, Vitamin B12 and folate.
2. Changes in immune function assessed by
WBC, immunoglobin (Ig) G and Ig A levels and
complete blood count (CBC).
3. Changes in energy levels assessed by fatigue
severity scale (FSS) score.
4. Changes in mental health assessed by Patient
Health Questionnaire (PHQ-9) score.
5. Changes in mental health assessed by
General Anxiety Disorder-7 (GAD-7) score. |
Screening, day 45 and day 90. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/11/2024 |
| 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="0"
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
|
Women’s health encompasses a broad spectrum of physiological and psychological
dimensions that are influenced by various nutritional factors. Given the dynamic phases in a
woman’s life, including menstruation, pregnancy, lactation, and menopause, ensuring
optimal nutrient intake is crucial. Multivitamin and mineral supplements (MVMS) have
been proposed to fill dietary gaps and support overall health and well-being. However, empirical evidence on their specific effects on general health markers, immune function, energy levels, and mental health in women remains limited.
This randomized, double-blind, placebo-controlled, multicenter clinical trial aims to
evaluate the efficacy and safety of an MVMS in improving general health and well-being
among women aged 18 to 55 years. The study will assess the impact on various health
markers, including nutrient levels, immune function, energy levels, and mental health. Over a 90-day period, we will conduct assessments at screening, day 45, and day 90. Primary and secondary endpoints will measure changes in self-reported health (SF-36
Health Survey), nutrient levels, immune function, energy levels, and mental health (PHQ-9
and GAD-7 scores). Adverse events, serious adverse events, treatment compliance, and
tolerability will be monitored throughout the study to ensure the safety of the participants. This clinical trial will provide robust evidence on the benefits of MVMS in women’s health. By evaluating a comprehensive range of health markers, the study aims to validate the role
of MVMS in enhancing general health, immune function, energy levels, and mental well- being. The findings will have significant implications for nutritional recommendations and
the development of targeted health interventions for women.
Each soft gelatin capsule of MVMS contains a balanced blend of vitamins, minerals, and
essential oils, including elemental magnesium, starflower oil, evening primrose oil, vitamin
C, nicotinamide, elemental iron, and several other vital nutrients. This formulation is
designed to address common nutritional deficiencies and support overall health in women. Therefore, a randomized, double blind, placebo controlled, multicenter clinical study is
planned to evaluate the effects of a Multivitamin Mineral Supplement on women’s health.
|