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Effect of Multi-Micronutrient Supplement Powder with Iron Folic Acid Tablets on Hemoglobin during Pregnancy

An Open - label, Parallel, Randomized Controlled Trial on the Effect of Multi-Micronutrient Supplement Powder with Iron Folic Acid Tablets on Hemoglobin during Pregnancy - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072457
Enrollment
160
Registered
2024-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: 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

Sponsors

Sri Madhusudan Sai Institute of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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, Crohnâ??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

Design outcomes

Primary

MeasureTime frame
Hemoglobin levels (g/dl) in pregnant womenTimepoint: Baseline, Follow up (after 3 months) and End line (at 9th month of gestation)

Secondary

MeasureTime frame
Birth weight (in grams) and length (in cms) of newbornsTimepoint: On the day of delivery

Countries

India

Contacts

Public ContactDr Sandhya Gowthaman

Sri Madhusudan Sai Institute of Medical Sciences and Research

satish.babu@smsimsr.org9731533636

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026