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

Sri Madhusudan Sai Institute of Medical Sciences and Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•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.

•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

发起方

Sri Madhusudan Sai Institute of Medical Sciences and Research