| CTRI Number |
CTRI/2025/02/080790 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to understand the effect of new micronutrients to improve pregnancy and child outcomes in pregnant women |
|
Scientific Title of Study
|
A randomized control trial to understand the effect of novel
nutrients for maternal, newborn, and child health in the rural community in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Beena Koshy |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Developmental Paediatrics,
Christian Medical College,
Vellore, Tamil Nadu.
Vellore TAMIL NADU 632004 India |
| Phone |
04162283260 |
| Fax |
|
| Email |
beenakurien@cmcvellore.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Beena Koshy |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Developmental Paediatrics,
Christian Medical College,
Vellore, Tamil Nadu.
Vellore TAMIL NADU 632004 India |
| Phone |
04162283260 |
| Fax |
|
| Email |
beenakurien@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Beena Koshy |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Developmental Paediatrics,
Christian Medical College,
Vellore, Tamil Nadu.
Vellore TAMIL NADU 632004 India |
| Phone |
04162283260 |
| Fax |
|
| Email |
beenakurien@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Bill and Melinda Gates Foundation, Seattle, USA |
|
|
Primary Sponsor
|
| Name |
Bill and Melinda Gates Foundation |
| Address |
P.O.Box 23350
Seattle, Washington, 98102
USA |
| Type of Sponsor |
Other [American Private Foundation] |
|
|
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 Beena Koshy |
Christian Medical College Vellore |
Developmental Paediatrics
CMC Vellore
Ida Scudder Road Vellore TAMIL NADU |
04162283260
beenakurien@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women with gestational age less than 14 weeks with no prior medical co-morbidity will be randomized to receive micronutrients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antenatal supplementation with novel micronutrients - nicotinamide, choline, and DHA (Docosohexanoic acid) |
Intervention will have standard care (Iron and folic acid, calcium supplementation) + nutrition advice +Zincovit+ Nicotinamide (100mg) + Choline (450mg) + DHA (200mg) for pregnant mothers till 6 months post-partum. |
| Comparator Agent |
Control - No Intervention |
Control - standard care + nutrition advice + Zincovit+ placebo for pregnant mothers till 6 months post-partum. Standard care includes Iron, Folic acid and Calcium supplementation currently followed in antenatal care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women with confirmed pregnancy with gestational age less than 14 weeks
2. Living in the recruitment geographical area and willing to spend the whole pregnancy in the area for the main study and 2-year postpartum for the sub-study
3. Singleton and viable fetus on ultrasound |
|
| ExclusionCriteria |
| Details |
1) Pregnant women with any known medical co-morbidities in the pre-pregnancy period (DM, HTN, Thyroid, SLE, etc)
2) Multipara with bad obstetric history
3) Any known food allergies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes
1. Effect on newborn outcomes - compound and individual outcomes (% low birth weight, % preterm, % small for gestation age, neonatal mortality, neonatal significant morbidity)
2. Effect on pregnancy outcomes - compound and individual pregnancy outcomes (loss, preterm, maternal morbidity, mortality)
3. Effect on birth weight
4. Childhood growth and development |
1. Newborn outcomes - birth/newborn period
2. Pregnancy outcomes - pregnancy monthly follow-up, birth
3. Birth weight -birth
4. Child growth
Monthly follow-ups till 24 months
Child development -6,12,18 and 24 months
Hyperfine neuroimaging - 6, 12 and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome/s:
1. Relationship between biochemical micronutrient & anemia status with childhood growth, development & brain morphometry.
2. Prevalence of iron deficiency & micronutrient deficiency anemia in pregnancy & early childhood
3. Effect of novel nutrients in improving maternal anemia & early childhood anemia
|
1. Child growth measured monthly postpartum till 24 months.
Child development -6,12,18 & 24 months
Hyperfine neuroimaging - 6, 12 &24 months
2. Pregnancy anemia prevalence- at recruitment
Childhood anemia - 6 months & 24 months post-partum
3. Effect of novel micronutrients on anemia
mothers - post-partum blood test
Children - 6 months & 24 months post-partum
|
|
|
Target Sample Size
|
Total Sample Size="1800" Sample Size from India="1800"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="4" Months="11" Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [beenakurien@cmcvellore.ac.in].
- For how long will this data be available start date provided 01-01-2029 and end date provided 31-12-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
The aim of the study is to understand the effect of antenatal supplementation with novel micronutrients - nicotinamide, choline, and DHA (docosohexanoic acid) on pregnancy and birth outcomes, as well as infant neurocognitive development in India. This will be a placebo-controlled randomized trial with two arms: the intervention arm will receive standard care, nutrition advice, Zincovit, and doses of nicotinamide (100 mg), choline (450 mg), and DHA (200 mg), while the control arm will receive standard care, nutrition advice, Zincovit, and a placebo. Standard care includes iron, folic acid, and calcium supplementation commonly followed in antenatal care. The study will recruit pregnant women aged 18-45 years who provide written informed consent at KV Kuppam block. It will focus on primary outcomes such as low birth weight prevalence, newborn outcomes, pregnancy outcomes, and childhood growth and development during the first two years of life along with childhood brain development assessed through hyperfine MRI imaging. Secondary outcomes will explore the relationship between biochemical micronutrient and anemia status with childhood growth, development and brain morphometry, prevalence of iron deficiency and micronutrient deficiency anemia during pregnancy and early childhood, and investigate the impact of novel micronutrients on improving anemia in mothers and young children. |