| CTRI Number |
CTRI/2025/08/093044 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Multiple Micronutrient Supplementation (Folic Acid, Niacin, and Iron) During Pregnancy Compared to Folic Acid Alone on Nutritional Health in Mothers |
|
Scientific Title of Study
|
Impact of Antenatal Multiple Micronutrient (Folic acid and Niacin and Iron) vs Folic Acid Supplementation on Nutritional Biomarkers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMM/IIS/25-003 Version 1.0dated Mar 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palaniappan N |
| Designation |
Professor of OBGYN |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Department of Obstetrics and gynaecology
Sri Ramachandra Hospitals
Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444407145 |
| Fax |
|
| Email |
palaniappan@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Palaniappan N |
| Designation |
Professor of OBGYN |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Department of Obstetrics and gynaecology
Sri Ramachandra Hospitals
Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444407145 |
| Fax |
|
| Email |
palaniappan@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Palaniappan N |
| Designation |
Professor of OBGYN |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Department of Obstetrics and gynaecology
Sri Ramachandra Hospitals
Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444407145 |
| Fax |
|
| Email |
palaniappan@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Fourrts (India) Laboratories Pvt.Limited |
|
|
Primary Sponsor
|
| Name |
Fourrts (India) Laboratories Pvt.Limited |
| Address |
1 Fourrts Avenue Annai Indira Nagar Okkiyam Thoraipakkam
Chennai India |
| 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 Nirmala Sadasivam |
Genesis IVF Advanced Fertility Centre |
564 Perundurai Road Erode 638001
Erode
TAMIL NADU |
9362766660
nirmalasadasivam1963@gmail.com |
| Palaniappan N |
Sri Ramachandra Hospital |
Department of Obstetrics and gynaecology
Sri Ramachandra Hospitals
Porur Chennai
Chennai
TAMIL NADU |
09444407145
palaniappan@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Erode Cancer Centre |
Approved |
| Institutional Ethics Committee Sri Ramachandra Institute of Higher Education & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Folic acid at a dose of 5 mg OD |
The subjects will receive the reference medication, i.e., Folic acid at a dose of 5 mg OD |
| Intervention |
PRENATAL TABLET |
1 tab once daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Time elapsed from the first day of the last menstrual period (LMP) not more than 8 weeks
Singleton live pregnancy
Willingness to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Women with severe anemia ( Hb 7g/L)
Recent consumption of antifolates (like methotrexate) folic acid antagonists (like valproic acid) or any medications known to interfere with folate absorption as per Investigator’s discretion
Prior pregnancy with neural tube defect (NTD) or any other congenital defect
Diagnosis of neural tube defect (NTD) in the biological father of the fetus or any blood relative of the patient
Diagnosis of epilepsy and seizure disorders
History of tumor
Family history of reproductive organ cancer
History of clinically significant complications including renal disease with altered renal function
History of any condition that could interfere with folate absorption or metabolism such as clinically significant gastrointestinal disease like chronic diarrhea inflammatory bowel disease partial gastrectomy unresolved gastrointestinal symptoms like diarrhea vomiting steatorrhea Pre existing maternal diabetes or insulin dependent diabetes
Alcohol abuse during current pregnancy
Illicit drug use during the current pregnancy as per the Investigator’s judgment
Known allergy hypersensitivity proven inefficiency or contraindications to the study medication any of its excipients or products containing any of the excipients
Participation in another clinical trial concurrently or within 30 days before screening
Planned participation in any other trial during the entire duration of the study
Refusal or inability to comply with the requirements of the protocol for any reason
Any other condition in the patient which in the opinion of the Investigator could confound the results of the trial put the patient at undue risk, or make the patient unsuitable for participation
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in maternal hemoglobin Hb gL from baseline to 20 weeks of gestation in both treatment arms
Change in maternal serum niacin nmolL levels from baseline to 20 weeks of gestation in both treatment arms
Change in maternal serum folate nmolL levels from baseline to 20 weeks of gestation in both treatment arms
|
To evaluate the effectiveness of L methylfolate niacin and iron based periconceptional supplementation compared to folic acid alone in improving maternal biomarkers related to nutritional status and anemia prevention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of participants experiencing maternal side effects (eg fatigue nausea vomiting) till 40 weeks or delivery in both treatment arms
Proportion of participants experiencing maternal morbidity outcomes pre eclampsia or eclampsia gestational hypertension premature rupture of membranes placental abruption infection during pregnancy need for blood transfusion) at week 40 or delivery in both treatment arms. |
Baseline week 0, week 12, week 20,week 32, week 40 or delivery |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
| The study will be initiated after obtaining written approval from the ethics committees of all study sites. Pregnant women 18 to 35 years will be enrolled if they provide written informed consent and satisfy all eligibility criteria. All possible demographic medical history comorbidities and other relevant clinical details will be recorded at baseline. Patients will undergo standard care as per routine practice in both treatment arms along with the test medication in treatment arm A and folic acid in treatment arm B. Enrolled subjects will be allotted in a ratio 11 into two treatment arms i subjects in the treatment arm A will undergo treatment with standard of care along with PreNatal® tablet 1 tablet once daily OD till 40 weeks of gestation ii subjects in the treatment arm B will undergo treatment with standard of care along with folic acid 5 mg OD. During inperson visits physical examination and examination of vital signs and clinical features will be done along with recording AEs concomitant medications and treatment compliance from baseline till week 40delivery. After clinical assessments blood samples 10 mL of venous blood from each subject will be collected and sent to the partner laboratory to estimate the maternal hemoglobin Hb gL maternal serum niacin nmolL and maternal serum folate nmolL at baseline and 20 weeks of gestation. All inperson visits after baseline are scheduled at 12th 20th 32nd weeks of gestation and the end of week 40delivery.Fetal parameters and maternal outcomes will be assessed at all in person visits during gestation and at delivery. | |