| CTRI Number |
CTRI/2024/11/077098 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
UK-South Asia collaboration to address maternal micronutrient deficiencies for improving babys brain development . |
|
Scientific Title of Study
|
A UK-South Asia Collaborative to address the impact of maternal micronutrient deficiencies on subsequent infant-neurodevelopment |
| Trial Acronym |
SACMIND |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jitender Nagpal |
| Designation |
Deputy Medical Director |
| Affiliation |
Sitaram Bhartia Institute of Science and Research |
| Address |
Room No. R-II, Ground Floor, Research Department, B-16, Qutab Institutional Area
South
DELHI
110016
India |
| Phone |
42111111 |
| Fax |
|
| Email |
jitendernagpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitender Nagpal |
| Designation |
Deputy Medical Director |
| Affiliation |
Sitaram Bhartia Institute of Science and Research |
| Address |
Room No. R-II, Ground Floor, Research Department, B-16, Qutab Institutional Area
DELHI
110016
India |
| Phone |
42111111 |
| Fax |
|
| Email |
jitendernagpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitender Nagpal |
| Designation |
Deputy Medical Director |
| Affiliation |
Sitaram Bhartia Institute of Science and Research |
| Address |
Room No. R-II, Ground Floor, Research Department, B-16, Qutab Institutional Area
DELHI
110016
India |
| Phone |
42111111 |
| Fax |
|
| Email |
jitendernagpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Health Research, Grange House, 15 Church Street, Twickenham TW1 3NL, United Kingdom |
|
|
Primary Sponsor
|
| Name |
Sitaram Bhartia Institute of Science and Research |
| Address |
Room No. R-II, Ground Floor, Research Department, B-16, Qutab Institutional Area, New Delhi-110016 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh
India
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jitender Nagpal |
Sitaram Bhartia Institute of Science and Research |
Room No. R-II, Ground Floor, Research Department, B-16, Qutab Institutional Area
South
DELHI |
01142111111
jitendernagpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sitaram Bhartia Institute of Science and Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mother of infant aged 9-12 months old |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Live baby 9-12 months of age |
|
| ExclusionCriteria |
| Details |
Major physical/mental illness precluding communication |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin |
At baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| B-12 levels, CBC, Vitamin D, iron studies |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="30"
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)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2025 |
| 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 Yet Recruiting |
| 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
|
Our overall goal of the partnership is to evaluate the role of maternal and early infancy micronutrient deficiencies in subsequent child neurodevelopment and to help address these inadequacies in South Asia. This will be achieved by developing an interdisciplinary collaborative involving Medical Researchers, Public Health Organisations, Women’s Health Groups, Social Scientists, Governmental health administrators and NGOs. The collaborative will identify lacunae in existing work on the subject, highlight areas for further research, study the socio-environmental determinants of such deficiencies and propose suitable implementation strategies for addressing micronutrient deficiencies with specific role in child neurodevelopment. Vitamins and minerals (micronutrients) play an important role in the human nutrition throughout life. While there has been recent emphasis on interventions to support child growth, the hidden hunger of micronutrient deficiencies during pregnancy and consequently in the new-born continues to be widely prevalent and widely neglected in LMICs. It is not surprising that the highest prevalence is reported amongst the most deprived sections. Recently, several studies have reported that specific micronutrient deficiencies like B-12, Vitamin D or iron could impact child neurodevelopment. However, there is paucity of comprehensive research towards potential interventions and corresponding implementation strategies that could address this lacuna especially in LMICs. Amongst the less understood aspects of potential micronutrient corrective measures are the role of Supplementation/fortification/dietary interventions, Single/multi-nutrient implementation, role of restrictive dietary practices in pregnancy, Maternal/infant/both supplementation, dosage/duration of supplementation, antenatal identification of risk factors/screening strategies. The importance of the issue cannot be overstated as it threatens to keep the “poor man’s child dumb†perpetuating a centuries old inequity. We hence propose the current plan to address this gap. We will conduct a scoping review of literature on the impact of micronutrient deficiencies on child neurodevelopment and the and determinants of such impact. Policy reviews will be used to identify potential opportunities for improvement. Appropriately timed workshops will be utilised to rate proposed interventions for effectiveness, cost, and sustainability. The gathered knowledge will be used to make appropriate modifications to the multicentric intervention plan. In parallel training/career developmental activities in strategically important areas will be used for building capacity in South Asian partner countries. Potential study sites for any major intervention/implementation work will be identified and analysed for suitability. This information will be used to specify a “Way Forward†for intervention studies and public health measures that could address the deficiency/ies. This will be done in partnership with all stakeholders including researchers, public health experts, pregnant women, governmental officials, non-governmental organisations and subject experts from UK, India, Nepal, Bangladesh, Sri-Lanka and Bhutan. In the longer term the partnership will engage with governmental health administrators across South Asia to co-develop an evidence based public health intervention plan based on the tested intervention. |