| 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
|
|
|
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
|
|
|
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
|
|
|
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. |