Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Iron supplement 30 mg: 30 mg Iron supplement(Emulsified Ferric Pyrophosphate) tablet
once a day for 16 weeks.
Intervention2: Iron supplement 60 mg: 60 mg Iron supplement(Emulsified Ferr
Sponsors
Generex Pharmassist Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in hemoglobin levels between groups on screening and every follow up visit till end of the studyTimepoint: Screening, week 4, week 8,and week 12 and week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3.Changes in serum iron between groups at screening & end of the study. 4.Changes in score of symptoms related to iron deficiency as well as gastrointestinal events between groups after iron supplementation such as breathlessness, palpitations, headaches, dizziness, irritability & constipation, abdominal discomfort, nausea & heartburn on 4-point ordinal scale. (0- none, 1- mild, 2- moderate, 3- severe) on screening, baseline, & every follow up visit till end of the studyTimepoint: Screening, week 4, week 8,and week 12 & week 16 | — |
Countries
India
Contacts
Public ContactDr Ankita Srivastav
Generex Pharmassist Pvt. Ltd.
Outcome results
None listed