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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [beenakurien@cmcvellore.ac.in].

  6. 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.

  7. 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.

 
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