Clinical study of Iron supplement in anemic pregnant wome

Phase 3

Conditions: Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium

Registration Number: CTRI/2024/07/070773

Lead Sponsor: Generex Pharmassist Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Participants meeting all of the following criteria will be eligible for the study: 1. Pregnant females with the age between 20-35 years (both inclusive); 2.Presence of a live, singleton, intrauterine fetus and dating ultrasound at screening that indicates a pregnancy that would be between the week 13 to week 16 (both inclusive); 3. Female with primi or multigravida;4. Pregnant females without any other comorbidity; 5. Hemoglobin levels between 9-10.5 g/dl (both inclusive); 6. With or without fatigue associated with anemia; 7. Serum ferritin levels below 15 mcg/L; 8. Able to give written informed consent;9. Able to follow up through visits.

Exclusion Criteria

Participants meeting any of the following criteria will not be eligible for the study: 1. Pregnant women of less than 13 weeks and more than 16 weeks of gestation; 2. Pregnant female with complicated pregnancy history or ongoing treatment for the same; 3. Pregnant women with complications like bleeding piles, excessive emesis, active peptic ulcer, diabetes, hypertension, eclampsia, hypothyroidism, hyperthyroidism and multiple pregnancy;

4. Fetal anomaly if detectable when an initial ultrasound is done to date the pregnancy; 5. Participants on any concomitant therapy for treating IDA during study period; 6. Not willing to provide consent or follow up; 7. Any condition from investigator viewpoint can affect participant participation in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Changes in hemoglobin levels at screening week 4, week 8 and end of the study. <br/ ><br>2. Adverse events profile from baseline to end of the study. <br/ ><br>Timepoint: Screening, baseline, week 4, week 8 and end of the study <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Changes in ferritin levels at screening, week 4, week 8 and end of the study. <br/ ><br>2.Changes in fatigue severity score at screening, week 4, week 8 and end of the study. <br/ ><br>3.Changes in serum iron at screening and end of the study. <br/ ><br>4.Changes in reticular haemoglobin (Hb) at screening and end of the study. <br/ ><br>5.Changes in score of symptoms related to iron deficiency as well as gastrointestinal events after iron supplementation such as breathlessness, palpitations, headaches, dizziness, irritability and constipation, abdominal discomfort, nausea and heartburn on 4-point ordinal scale. (0- none, 1- mild, 2- moderate, 3- severe) at screening, baseline, week 4, week 8 and end of the study. <br/ ><br>Timepoint: Screening, baseline, week 4, week 8 and end of the study.