Clinical trial of Iron supplement in anemic pregnant women.

Not yet recruiting

Conditions: Iron deficiency anemia, unspecified,

Registration Number: CTRI/2022/11/047376

Lead Sponsor: Generex Pharmassist Pvt. Ltd.

Brief Summary: The present research is an attempt to clinically validate the effectiveness of Iron supplement with different doses in pregnant patients suffering from iron deficiency anemia (IDA). With the present research, we can apply the knowledge from previous studies and clinical trials to address important medical needs in pregnant IDA to improve effectiveness and reduce the anticipated side effects with better compliance in improving IDA status. We can utilize these outcomes to develop a strategy for treating IDA in pregnant females in a more appropriate and assured way.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Pregnant females with age between 18-40 years (Both inclusive) 2.
Presence of a live, singleton, intrauterine fetus and dating ultrasound at screening that indicates a pregnancy that would be between week 13 to week 20 (both inclusive) 3.
Female with primi or multigravida 4.
Pregnant females without any other comorbidity 5.
Hemoglobin levels between 9-10.5 gm/dl (Bothinclusive) 6.
With or without the fatigue associated with anemia 7.
Serum ferritin levels between 10-15 mcg/L (Both inclusive) 8.
Able to give written informed consent 9.
Able to follow up through visits.

Exclusion Criteria

1.Pregnant women of less than 13 weeks and more than 20 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 and hyperthyroidism and multiple pregnancy;4.Fetal anomaly if detectable when an initial ultrasound is done to date the pregnancy; 5.Subjects 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 patient participation in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in hemoglobin levels between groups on screening and every follow up visit till end of the study	Screening, week 4, week 8,and week 12 and week 16

Secondary Outcome Measures

Name	Time	Method
1.Changes in Ferritin levels between groups on screening & every follow up visit till end of the study.	2.Changes in fatigue severity score between groups on screening & every follow up visit till end of the study.

Trial Locations

Locations (2): Lifepoint Multispeciality Hospital
🇮🇳
Pune, MAHARASHTRA, India
Lokmanya Medical Research Centre and Hospital
🇮🇳
Pune, MAHARASHTRA, India
Lifepoint Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Adhav Tejasvini Kishor
Principal investigator
8805785212
adhav.tejasvini121@gmail.com