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CTRI Number  CTRI/2024/08/072457 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 07/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Multi-Micronutrient Supplement Powder with Iron Folic Acid Tablets on Hemoglobin during Pregnancy  
Scientific Title of Study   An Open - label, Parallel, Randomized Controlled Trial on the Effect of Multi-Micronutrient Supplement Powder with Iron Folic Acid Tablets on Hemoglobin during Pregnancy  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Satish Babu 
Designation  Professor, General Medicine and Director, Academics and Quality 
Affiliation  Sri Madhusudan Sai Institute of Medical Sciences and Research 
Address  Professor, Department of General Medicine, Rajeshwari Block, Sri Madhusudan Sai Institute of Medical Sciences and Research, Sathya Sai Grama, Muddenahalli, Chikkaballapura, Karnataka 562101

Bangalore Rural
KARNATAKA
562101
India 
Phone  9731533636  
Fax    
Email  satish.babu@smsimsr.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satish Babu 
Designation  Professor, General Medicine and Director, Academics and Quality 
Affiliation  Sri Madhusudan Sai Institute of Medical Sciences and Research 
Address  Professor, Department of General Medicine, Rajeshwari Block, Sri Madhusudan Sai Institute of Medical Sciences and Research, Sathya Sai Grama, Muddenahalli, Chikkaballapura, Karnataka 562101

Bangalore Rural
KARNATAKA
562101
India 
Phone  9731533636  
Fax    
Email  satish.babu@smsimsr.org  
 
Details of Contact Person
Public Query
 
Name  Dr Sandhya Gowthaman 
Designation  Senior Resident, Community Medicine 
Affiliation  Sri Madhusudan Sai Institute of Medical Sciences and Research 
Address  Senior Resident, Department of Community Medicine, Kripashriya Block, Sri Madhusudan Sai Institute of Medical Sciences and Research, Sathya Sai Grama, Muddenahalli, Chikkaballapura, Karnataka 562101

Bangalore Rural
KARNATAKA
562101
India 
Phone  9566194032  
Fax    
Email  sandhya.g@smsimsr.org  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sri Madhusudan Sai Institute of Medical Sciences and Research 
Address  Sri Madhusudan Sai Institute of Medical Sciences and Research, Sathya Sai Grama, Muddenahalli, Chikkaballapur, Karnataka - 562101 
Type of Sponsor  Private medical college 
 
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 Satish Babu  Department of Obstetrics and Gynecology, SMSIMSR  Sri Madhusudan Sai Institute of Medical Sciences and Research, Sathya Sai Grama, Muddenahalli, Chikkaballapur, Karnataka - 562101
Bangalore Rural
KARNATAKA 
9731533636

satish.babu@smsimsr.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Sathya Sai University for Human Excellence  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi - micronutrient supplement powder   The intervention group will receive standard care, Iron Folic Acid tablets (50 mg elemental iron and 500 mcg folic acid) and Multi-Micronutrient Supplement powder (15 g per day) required for 30 days during each monthly visit (from 4th month till delivery). The supplement powder will be given free of cost to the study participants. The contents of the supplement powder are within the Recommended Daily Allowance and Tolerable Upper Limits for pregnant women as per the National Institute of Nutrition (NIN) guidelines. 
Comparator Agent  Standard care and Iron Folic Acid Tablets  The control group will receive standard care and 30 Iron Folic Acid tablets (50 mg elemental iron and 500 mcg folic acid during every monthly visit until delivery. (from 4th month till delivery). Composition of IFA tablets (Hemolab forte-Z) provided in both groups are Carbonyl Iron (Equivalent to 50 mg elemental iron), Zinc sulfate monohydrate (Equivalent to 22.5 mg elemental Zinc) and Folic acid (0.5mg)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women aged 18 to 35 years with 12 to 16 weeks of gestation and Hemoglobin above 8 g % and willing to give consent for the study. 
 
ExclusionCriteria 
Details  1. Those already started on IFA tablets/other multi-nutrient supplements
2. Pregnant women currently enrolled in another clinical trial.
3. Previously received transfusion or known case of anemia on treatment in the last 6 months prior to presentation.
4.Pregnant women with known:
a. Pre-existing medical conditions like diabetes, HIV / AIDS, heart diseases, hypertension, asthma, renal failure, epilepsy, which are known to affect the outcome.
b. Chronic gastrointestinal issues like Malabsorption syndromes, Inflammatory Bowel Disease, chronic pancreatitis, Crohn’s disease, ulcerative colitis, or chronic diarrhea.
c. Hematological (blood) disorders like thalassemia, sickle cell anemia, or other hemoglobinopathies.
d. Severe malnutrition or significant weight loss that could impact the study results.
e. Allergies or hypersensitivity to any component of the multiple micronutrient powder.
f. Severe mental health conditions that could affect their ability to comply with the study protocol.
g. Active infectious diseases like tuberculosis or malaria.
5. Multiple pregnancy
6. Women who have had a severe illness or major surgery within 6 months before enrollment.
7. Women identified as having high-risk pregnancies due to factors like advanced maternal age or previous pregnancy complications.
8. Women with diagnosed deficiencies in nutrients not included in the micronutrient powder, which could confound results.
9. Women with precious pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Hemoglobin levels (g/dl) in pregnant women  Baseline, Follow up (after 3 months) and End line (at 9th month of gestation)  
 
Secondary Outcome  
Outcome  TimePoints 
Birth weight (in grams) and length (in cms) of newborns  On the day of delivery 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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 2 
Date of First Enrollment (India)   19/08/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 is designed as an open-label, parallel, superiority randomized controlled trial. The study will be conducted at the Obstetrics OPD, Sri Madhusudan Sai Institute of Medical Sciences and Research from July 2024 to June 2025. The study population includes pregnant women aged 18 to 35 years who are registered at 12 to 16 weeks of gestation and have not started on Iron Folic Acid supplementation, with Hemoglobin levels above 8 g / dL. Consecutive sampling will be used, and the sample size is calculated to include 160 participants, with 80 in each group. Eligible participants will provide informed consent and be assigned a unique study ID. Randomization will be conducted using a Microsoft Excel-generated sequence with a 1:1 allocation ratio, concealed from the recruitment team. The intervention group will receive standard care, Iron Folic Acid tablets, and a Multi-Micronutrient Supplement powder, while the control group will receive standard care and Iron Folic Acid tablets only. Data collection will be done at baseline, monthly follow-up, and end line. Hemoglobin will be measured at baseline, after 3 months, and in the 9th month of pregnancy, with neonatal birth weight and length recorded at delivery. Peripheral smear will be done for those pregnant women with Hemogobin 8 to 10.99 g / dl, and serum ferritin and Vitamin B 12 will be done based on the peripheral smear report. Ethical clearance will be obtained from the Institutional Ethics Committee prior to the study initiation.

 
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