Brief Summary

Hypothesis: Synergistic effect of pre-biotics and iron fortificants will enhance the bioavailability of iron; thereby improving the body iron reserves. A double blind, randomized controlled trail will be conducted on iron deficient female adults (age 18-25 years) in order to determine the synergistic effect of pre-biotics and iron fortificants in anemic human subjects. 75 iron deficient females will be randomly divided into 5 groups (D0, D1, D2, D3 and D4), each having 15 study subjects and will be given varying doses of FeSO4 and NaFeEDTA and Inulin and GOS. Blood samples will be collected from overnight fasted women from each group on monthly basis up to three months. Various biomarkers for iron absorption, LFTs, RFTs, and Immunoglobulins will be estimated.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Apr 2019

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 months study duration

First Submitted

Initial submission to the registry

March 25, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed

9 days until next milestone

Study Start

First participant enrolled

April 6, 2019

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2019

Completed

2 months until next milestone

Results Posted

Study results publicly available

August 22, 2019

Completed

Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

March 25, 2019

Results QC Date

July 13, 2019

Last Update Submit

August 20, 2019

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (11)

Change in Hemoglobin Concentration From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Hematocrit in Concentration From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Volume From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Serum Iron Levels From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Serum Folate Levels From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Serum Ferritin Levels From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Serum Transferrin Levels From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days

Secondary Outcomes (10)

Change in Liver Functions Tests (ALT) From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (AST) From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (ALP) From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
Baseline, 30 days, 60 days, 90 days
+5 more secondary outcomes