Trial Outcomes & Findings for Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic Subjects (NCT NCT03894449)
NCT ID: NCT03894449
Last Updated: 2019-08-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Baseline, 30 days, 60 days, 90 days
Results posted on
2019-08-22
Participant Flow
Participant milestones
| Measure |
Placebo Only
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA (2)
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeS04
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA (2)
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeS04
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
75 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=75 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
75 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=75 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Pakistan
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
75 participants
n=75 Participants
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Hemoglobin Concentration From Baseline to 90 Days
Baseline
|
11.44 g/dL
Standard Deviation 0.04
|
11.58 g/dL
Standard Deviation 0.02
|
11.54 g/dL
Standard Deviation 0.01
|
11.61 g/dL
Standard Deviation 0.02
|
11.28 g/dL
Standard Deviation 0.04
|
|
Change in Hemoglobin Concentration From Baseline to 90 Days
30 days
|
11.52 g/dL
Standard Deviation 0.01
|
11.71 g/dL
Standard Deviation 0.01
|
11.62 g/dL
Standard Deviation 0.01
|
11.78 g/dL
Standard Deviation 0.03
|
11.54 g/dL
Standard Deviation 0.02
|
|
Change in Hemoglobin Concentration From Baseline to 90 Days
60 days
|
11.64 g/dL
Standard Deviation 0.01
|
11.83 g/dL
Standard Deviation 0.01
|
11.74 g/dL
Standard Deviation 0.01
|
11.90 g/dL
Standard Deviation 0.01
|
11.84 g/dL
Standard Deviation 0.02
|
|
Change in Hemoglobin Concentration From Baseline to 90 Days
90 days
|
11.91 g/dL
Standard Deviation 0.02
|
12.04 g/dL
Standard Deviation 0.03
|
11.85 g/dL
Standard Deviation 0.01
|
12.17 g/dL
Standard Deviation 0.04
|
12.33 g/dL
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Hematocrit in Concentration From Baseline to 90 Days
Baseline
|
30.26 % of RBCs in blood
Standard Deviation 0.17
|
33.76 % of RBCs in blood
Standard Deviation 0.19
|
32.77 % of RBCs in blood
Standard Deviation 0.07
|
33.50 % of RBCs in blood
Standard Deviation 0.06
|
31.50 % of RBCs in blood
Standard Deviation 0.06
|
|
Change in Hematocrit in Concentration From Baseline to 90 Days
30 days
|
31.62 % of RBCs in blood
Standard Deviation 0.04
|
34.84 % of RBCs in blood
Standard Deviation 0.12
|
33.72 % of RBCs in blood
Standard Deviation 0.08
|
34.59 % of RBCs in blood
Standard Deviation 0.09
|
33.81 % of RBCs in blood
Standard Deviation 0.13
|
|
Change in Hematocrit in Concentration From Baseline to 90 Days
60 days
|
32.65 % of RBCs in blood
Standard Deviation 0.03
|
35.14 % of RBCs in blood
Standard Deviation 0.10
|
34.76 % of RBCs in blood
Standard Deviation 0.17
|
35.60 % of RBCs in blood
Standard Deviation 0.07
|
35.24 % of RBCs in blood
Standard Deviation 0.06
|
|
Change in Hematocrit in Concentration From Baseline to 90 Days
90 days
|
34.36 % of RBCs in blood
Standard Deviation 0.16
|
36.43 % of RBCs in blood
Standard Deviation 0.07
|
36.17 % of RBCs in blood
Standard Deviation 0.07
|
36.56 % of RBCs in blood
Standard Deviation 0.06
|
37.86 % of RBCs in blood
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Mean Corpuscular Volume From Baseline to 90 Days
Baseline
|
68.53 fL
Standard Deviation 0.11
|
69.56 fL
Standard Deviation 0.11
|
73.79 fL
Standard Deviation 0.19
|
76.61 fL
Standard Deviation 0.13
|
78.06 fL
Standard Deviation 0.09
|
|
Change in Mean Corpuscular Volume From Baseline to 90 Days
30 days
|
70.46 fL
Standard Deviation 0.29
|
71.63 fL
Standard Deviation 0.24
|
74.70 fL
Standard Deviation 0.17
|
78.77 fL
Standard Deviation 0.14
|
80.03 fL
Standard Deviation 0.13
|
|
Change in Mean Corpuscular Volume From Baseline to 90 Days
60 days
|
72.72 fL
Standard Deviation 0.09
|
75.11 fL
Standard Deviation 0.49
|
80.18 fL
Standard Deviation 0.17
|
81.82 fL
Standard Deviation 0.17
|
81.96 fL
Standard Deviation 0.14
|
|
Change in Mean Corpuscular Volume From Baseline to 90 Days
90 days
|
77.09 fL
Standard Deviation 0.15
|
78.64 fL
Standard Deviation 0.17
|
83.77 fL
Standard Deviation 0.13
|
83.64 fL
Standard Deviation 0.15
|
85.59 fL
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
Baseline
|
21.94 pg
Standard Deviation 1.35
|
23.63 pg
Standard Deviation 1.02
|
20.63 pg
Standard Deviation 0.79
|
24.02 pg
Standard Deviation 0.69
|
24.56 pg
Standard Deviation 0.79
|
|
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
30 days
|
23.24 pg
Standard Deviation 1.14
|
24.83 pg
Standard Deviation 0.86
|
21.86 pg
Standard Deviation 0.74
|
25.31 pg
Standard Deviation 1.08
|
27.42 pg
Standard Deviation 0.66
|
|
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
60 days
|
24.47 pg
Standard Deviation 1.00
|
25.05 pg
Standard Deviation 0.45
|
24.29 pg
Standard Deviation 0.69
|
26.47 pg
Standard Deviation 0.28
|
28.26 pg
Standard Deviation 0.88
|
|
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
90 days
|
25.09 pg
Standard Deviation 0.89
|
26.76 pg
Standard Deviation 0.59
|
26.28 pg
Standard Deviation 0.51
|
26.93 pg
Standard Deviation 0.26
|
30.75 pg
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
Baseline
|
31.44 g/dL
Standard Deviation 0.77
|
29.30 g/dL
Standard Deviation 0.79
|
28.06 g/dL
Standard Deviation 0.31
|
29.05 g/dL
Standard Deviation 0.50
|
28.51 g/dL
Standard Deviation 0.38
|
|
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
30 days
|
31.07 g/dL
Standard Deviation 0.74
|
30.30 g/dL
Standard Deviation 1.11
|
30.08 g/dL
Standard Deviation 0.76
|
30.74 g/dL
Standard Deviation 0.67
|
30.67 g/dL
Standard Deviation 0.77
|
|
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
60 days
|
31.70 g/dL
Standard Deviation 0.45
|
31.91 g/dL
Standard Deviation 0.59
|
31.19 g/dL
Standard Deviation 0.94
|
33.42 g/dL
Standard Deviation 0.96
|
34.25 g/dL
Standard Deviation 0.85
|
|
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
90 days
|
32.78 g/dL
Standard Deviation 0.58
|
33.46 g/dL
Standard Deviation 0.83
|
33.13 g/dL
Standard Deviation 0.94
|
34.15 g/dL
Standard Deviation 1.06
|
36.91 g/dL
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Serum Iron Levels From Baseline to 90 Days
Baseline
|
68.41 mcg/dL
Standard Deviation 0.70
|
70.97 mcg/dL
Standard Deviation 0.70
|
72.65 mcg/dL
Standard Deviation 0.50
|
71.41 mcg/dL
Standard Deviation 0.60
|
72.60 mcg/dL
Standard Deviation 0.33
|
|
Change in Serum Iron Levels From Baseline to 90 Days
30 days
|
69.17 mcg/dL
Standard Deviation 0.85
|
72.34 mcg/dL
Standard Deviation 1.01
|
73.95 mcg/dL
Standard Deviation 0.77
|
72.62 mcg/dL
Standard Deviation 0.73
|
74.51 mcg/dL
Standard Deviation 0.39
|
|
Change in Serum Iron Levels From Baseline to 90 Days
60 days
|
70.25 mcg/dL
Standard Deviation 0.85
|
74.34 mcg/dL
Standard Deviation 1.12
|
75.50 mcg/dL
Standard Deviation 0.90
|
73.96 mcg/dL
Standard Deviation 0.99
|
76.61 mcg/dL
Standard Deviation 0.53
|
|
Change in Serum Iron Levels From Baseline to 90 Days
90 days
|
70.93 mcg/dL
Standard Deviation 0.95
|
75.36 mcg/dL
Standard Deviation 1.23
|
77.42 mcg/dL
Standard Deviation 0.91
|
76.16 mcg/dL
Standard Deviation 1.09
|
79.10 mcg/dL
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Serum Folate Levels From Baseline to 90 Days
Baseline
|
8.74 ng/mL
Standard Deviation 0.12
|
9.26 ng/mL
Standard Deviation 0.18
|
8.05 ng/mL
Standard Deviation 0.08
|
8.96 ng/mL
Standard Deviation 0.11
|
8.20 ng/mL
Standard Deviation 0.05
|
|
Change in Serum Folate Levels From Baseline to 90 Days
30 days
|
8.81 ng/mL
Standard Deviation 0.11
|
10.03 ng/mL
Standard Deviation 0.17
|
8.32 ng/mL
Standard Deviation 0.10
|
9.40 ng/mL
Standard Deviation 0.12
|
9.97 ng/mL
Standard Deviation 0.07
|
|
Change in Serum Folate Levels From Baseline to 90 Days
60 days
|
8.88 ng/mL
Standard Deviation 0.09
|
10.31 ng/mL
Standard Deviation 0.15
|
8.99 ng/mL
Standard Deviation 0.11
|
9.75 ng/mL
Standard Deviation 0.13
|
10.87 ng/mL
Standard Deviation 0.12
|
|
Change in Serum Folate Levels From Baseline to 90 Days
90 days
|
8.94 ng/mL
Standard Deviation 0.09
|
10.74 ng/mL
Standard Deviation 0.16
|
9.46 ng/mL
Standard Deviation 0.13
|
10.02 ng/mL
Standard Deviation 0.14
|
11.01 ng/mL
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Serum Ferritin Levels From Baseline to 90 Days
Baseline
|
11.76 ng/mL
Standard Deviation 0.11
|
13.73 ng/mL
Standard Deviation 0.18
|
13.29 ng/mL
Standard Deviation 0.31
|
12.03 ng/mL
Standard Deviation 0.09
|
12.67 ng/mL
Standard Deviation 0.23
|
|
Change in Serum Ferritin Levels From Baseline to 90 Days
30 days
|
11.86 ng/mL
Standard Deviation 0.08
|
14.09 ng/mL
Standard Deviation 0.53
|
13.59 ng/mL
Standard Deviation 0.34
|
12.86 ng/mL
Standard Deviation 0.10
|
13.56 ng/mL
Standard Deviation 0.24
|
|
Change in Serum Ferritin Levels From Baseline to 90 Days
60 days
|
11.98 ng/mL
Standard Deviation 0.09
|
16.28 ng/mL
Standard Deviation 0.54
|
14.31 ng/mL
Standard Deviation 0.37
|
13.37 ng/mL
Standard Deviation 0.14
|
14.77 ng/mL
Standard Deviation 0.25
|
|
Change in Serum Ferritin Levels From Baseline to 90 Days
90 days
|
12.04 ng/mL
Standard Deviation 0.17
|
16.88 ng/mL
Standard Deviation 0.55
|
15.77 ng/mL
Standard Deviation 0.36
|
15.10 ng/mL
Standard Deviation 0.27
|
17.55 ng/mL
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Serum Transferrin Levels From Baseline to 90 Days
Baseline
|
16.84 mg/dL
Standard Deviation 0.05
|
16.74 mg/dL
Standard Deviation 0.09
|
16.38 mg/dL
Standard Deviation 0.08
|
16.79 mg/dL
Standard Deviation 0.07
|
17.15 mg/dL
Standard Deviation 0.06
|
|
Change in Serum Transferrin Levels From Baseline to 90 Days
30 days
|
16.74 mg/dL
Standard Deviation 0.04
|
16.63 mg/dL
Standard Deviation 0.09
|
16.30 mg/dL
Standard Deviation 0.09
|
16.69 mg/dL
Standard Deviation 0.10
|
16.97 mg/dL
Standard Deviation 0.04
|
|
Change in Serum Transferrin Levels From Baseline to 90 Days
60 days
|
16.55 mg/dL
Standard Deviation 0.09
|
16.52 mg/dL
Standard Deviation 0.11
|
16.21 mg/dL
Standard Deviation 0.09
|
16.59 mg/dL
Standard Deviation 0.14
|
16.69 mg/dL
Standard Deviation 0.16
|
|
Change in Serum Transferrin Levels From Baseline to 90 Days
90 days
|
16.44 mg/dL
Standard Deviation 0.08
|
16.41 mg/dL
Standard Deviation 0.13
|
16.09 mg/dL
Standard Deviation 0.10
|
16.46 mg/dL
Standard Deviation 0.08
|
16.47 mg/dL
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
Baseline
|
16.92 % Transferrin
Standard Deviation 0.20
|
17.66 % Transferrin
Standard Deviation 0.24
|
18.49 % Transferrin
Standard Deviation 0.19
|
17.73 % Transferrin
Standard Deviation 0.14
|
17.64 % Transferrin
Standard Deviation 0.10
|
|
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
30 days
|
17.22 % Transferrin
Standard Deviation 0.23
|
18.13 % Transferrin
Standard Deviation 0.32
|
18.91 % Transferrin
Standard Deviation 0.23
|
18.13 % Transferrin
Standard Deviation 0.19
|
18.29 % Transferrin
Standard Deviation 0.13
|
|
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
60 days
|
17.69 % Transferrin
Standard Deviation 0.19
|
18.75 % Transferrin
Standard Deviation 0.38
|
19.41 % Transferrin
Standard Deviation 0.27
|
18.58 % Transferrin
Standard Deviation 0.26
|
19.13 % Transferrin
Standard Deviation 0.16
|
|
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
90 days
|
17.98 % Transferrin
Standard Deviation 0.20
|
19.13 % Transferrin
Standard Deviation 0.42
|
20.05 % Transferrin
Standard Deviation 0.30
|
19.28 % Transferrin
Standard Deviation 0.33
|
20.02 % Transferrin
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
Baseline
|
404.26 mcg/dL
Standard Deviation 1.16
|
401.81 mcg/dL
Standard Deviation 2.12
|
393.06 mcg/dL
Standard Deviation 1.93
|
402.84 mcg/dL
Standard Deviation 1.68
|
411.67 mcg/dL
Standard Deviation 1.53
|
|
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
30 days
|
401.75 mcg/dL
Standard Deviation 1.07
|
399.06 mcg/dL
Standard Deviation 2.19
|
391.08 mcg/dL
Standard Deviation 2.06
|
400.55 mcg/dL
Standard Deviation 1.72
|
407.29 mcg/dL
Standard Deviation 1.61
|
|
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
60 days
|
397.21 mcg/dL
Standard Deviation 2.16
|
396.57 mcg/dL
Standard Deviation 2.62
|
388.93 mcg/dL
Standard Deviation 2.09
|
398.17 mcg/dL
Standard Deviation 1.63
|
400.57 mcg/dL
Standard Deviation 1.52
|
|
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
90 days
|
394.63 mcg/dL
Standard Deviation 2.04
|
393.92 mcg/dL
Standard Deviation 3.17
|
386.16 mcg/dL
Standard Deviation 2.30
|
395.03 mcg/dL
Standard Deviation 1.95
|
395.20 mcg/dL
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Liver Functions Tests (ALT) From Baseline to 90 Days
Baseline ALT
|
10.51 IU/L
Standard Deviation 0.10
|
11.80 IU/L
Standard Deviation 0.18
|
15.18 IU/L
Standard Deviation 0.44
|
14.73 IU/L
Standard Deviation 0.08
|
11.59 IU/L
Standard Deviation 0.31
|
|
Change in Liver Functions Tests (ALT) From Baseline to 90 Days
30 days ALT
|
10.61 IU/L
Standard Deviation 0.23
|
11.10 IU/L
Standard Deviation 0.35
|
14.31 IU/L
Standard Deviation 0.52
|
13.24 IU/L
Standard Deviation 0.45
|
10.54 IU/L
Standard Deviation 0.56
|
|
Change in Liver Functions Tests (ALT) From Baseline to 90 Days
60 days ALT
|
10.59 IU/L
Standard Deviation 0.24
|
10.69 IU/L
Standard Deviation 0.40
|
12.85 IU/L
Standard Deviation 0.76
|
12.32 IU/L
Standard Deviation 0.75
|
9.75 IU/L
Standard Deviation 0.70
|
|
Change in Liver Functions Tests (ALT) From Baseline to 90 Days
90 days ALT
|
11.28 IU/L
Standard Deviation 0.60
|
10.27 IU/L
Standard Deviation 0.40
|
11.81 IU/L
Standard Deviation 0.84
|
11.13 IU/L
Standard Deviation 0.89
|
9.27 IU/L
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Liver Functions Tests (AST) From Baseline to 90 Days
Baseline AST
|
16.83 IU/L
Standard Deviation 0.15
|
15.93 IU/L
Standard Deviation 0.53
|
18.07 IU/L
Standard Deviation 0.11
|
18.77 IU/L
Standard Deviation 0.14
|
16.09 IU/L
Standard Deviation 0.26
|
|
Change in Liver Functions Tests (AST) From Baseline to 90 Days
30 days AST
|
16.81 IU/L
Standard Deviation 0.14
|
15.76 IU/L
Standard Deviation 0.54
|
17.13 IU/L
Standard Deviation 0.19
|
18.90 IU/L
Standard Deviation 0.82
|
15.99 IU/L
Standard Deviation 0.21
|
|
Change in Liver Functions Tests (AST) From Baseline to 90 Days
60 days AST
|
16.68 IU/L
Standard Deviation 0.13
|
15.73 IU/L
Standard Deviation 0.55
|
17.04 IU/L
Standard Deviation 0.22
|
18.80 IU/L
Standard Deviation 0.85
|
15.87 IU/L
Standard Deviation 0.27
|
|
Change in Liver Functions Tests (AST) From Baseline to 90 Days
90 days AST
|
16.55 IU/L
Standard Deviation 0.11
|
15.62 IU/L
Standard Deviation 0.56
|
16.84 IU/L
Standard Deviation 0.25
|
18.78 IU/L
Standard Deviation 0.90
|
15.75 IU/L
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Liver Functions Tests (ALP) From Baseline to 90 Days
Baseline ALP
|
65.84 IU/L
Standard Deviation 1.54
|
69.35 IU/L
Standard Deviation 0.76
|
73.92 IU/L
Standard Deviation 1.33
|
74.99 IU/L
Standard Deviation 1.25
|
68.43 IU/L
Standard Deviation 1.31
|
|
Change in Liver Functions Tests (ALP) From Baseline to 90 Days
30 days ALP
|
65.63 IU/L
Standard Deviation 2.03
|
71.07 IU/L
Standard Deviation 0.72
|
73.77 IU/L
Standard Deviation 1.32
|
74.86 IU/L
Standard Deviation 1.23
|
68.37 IU/L
Standard Deviation 1.30
|
|
Change in Liver Functions Tests (ALP) From Baseline to 90 Days
60 days ALP
|
65.51 IU/L
Standard Deviation 1.41
|
73.34 IU/L
Standard Deviation 0.73
|
73.42 IU/L
Standard Deviation 1.36
|
74.72 IU/L
Standard Deviation 1.24
|
68.19 IU/L
Standard Deviation 1.24
|
|
Change in Liver Functions Tests (ALP) From Baseline to 90 Days
90 days ALP
|
65.48 IU/L
Standard Deviation 1.38
|
76.06 IU/L
Standard Deviation 0.71
|
73.14 IU/L
Standard Deviation 1.35
|
74.55 IU/L
Standard Deviation 1.19
|
68.12 IU/L
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
Baseline Total Bilirubin
|
0.31 mg/dL
Standard Deviation 0.02
|
0.44 mg/dL
Standard Deviation 0.02
|
0.47 mg/dL
Standard Deviation 0.02
|
0.61 mg/dL
Standard Deviation 0.05
|
0.35 mg/dL
Standard Deviation 0.03
|
|
Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
30 days Total Bilirubin
|
0.31 mg/dL
Standard Deviation 0.03
|
0.41 mg/dL
Standard Deviation 0.03
|
0.43 mg/dL
Standard Deviation 0.03
|
0.55 mg/dL
Standard Deviation 0.07
|
0.20 mg/dL
Standard Deviation 0.04
|
|
Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
60 days Total Bilirubin
|
0.26 mg/dL
Standard Deviation 0.04
|
0.36 mg/dL
Standard Deviation 0.05
|
0.41 mg/dL
Standard Deviation 0.04
|
0.51 mg/dL
Standard Deviation 0.08
|
0.13 mg/dL
Standard Deviation 0.05
|
|
Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
90 days Total Bilirubin
|
0.19 mg/dL
Standard Deviation 0.06
|
0.27 mg/dL
Standard Deviation 0.07
|
0.28 mg/dL
Standard Deviation 0.07
|
0.43 mg/dL
Standard Deviation 0.06
|
0.11 mg/dL
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
Baseline Serum Urea
|
18.86 mg/dL
Standard Deviation 0.13
|
17.59 mg/dL
Standard Deviation 0.19
|
19.60 mg/dL
Standard Deviation 0.33
|
21.02 mg/dL
Standard Deviation 0.46
|
21.55 mg/dL
Standard Deviation 0.27
|
|
Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
30 days Serum Urea
|
18.53 mg/dL
Standard Deviation 0.20
|
17.77 mg/dL
Standard Deviation 0.18
|
19.63 mg/dL
Standard Deviation 0.34
|
21.01 mg/dL
Standard Deviation 0.44
|
21.56 mg/dL
Standard Deviation 0.29
|
|
Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
60 days Serum Urea
|
18.23 mg/dL
Standard Deviation 0.21
|
17.86 mg/dL
Standard Deviation 0.17
|
19.65 mg/dL
Standard Deviation 0.35
|
21.06 mg/dL
Standard Deviation 0.47
|
21.59 mg/dL
Standard Deviation 0.31
|
|
Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
90 days Serum Urea
|
18.01 mg/dL
Standard Deviation 0.10
|
17.92 mg/dL
Standard Deviation 0.20
|
19.10 mg/dL
Standard Deviation 2.51
|
21.04 mg/dL
Standard Deviation 0.55
|
21.65 mg/dL
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days
60 days Serum Creatinine
|
0.78 mg/dL
Standard Deviation 0.03
|
0.90 mg/dL
Standard Deviation 0.03
|
0.95 mg/dL
Standard Deviation 0.02
|
0.77 mg/dL
Standard Deviation 0.05
|
0.84 mg/dL
Standard Deviation 0.05
|
|
Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days
90 days Serum Creatinine
|
0.80 mg/dL
Standard Deviation 0.02
|
0.93 mg/dL
Standard Deviation 0.03
|
0.92 mg/dL
Standard Deviation 0.03
|
0.86 mg/dL
Standard Deviation 0.06
|
0.94 mg/dL
Standard Deviation 0.03
|
|
Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days
Baseline Serum Creatinine
|
0.77 mg/dL
Standard Deviation 0.02
|
0.83 mg/dL
Standard Deviation 0.02
|
0.89 mg/dL
Standard Deviation 0.01
|
0.62 mg/dL
Standard Deviation 0.02
|
0.65 mg/dL
Standard Deviation 0.02
|
|
Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days
30 days Serum Creatinine
|
0.76 mg/dL
Standard Deviation 0.03
|
0.86 mg/dL
Standard Deviation 0.03
|
0.93 mg/dL
Standard Deviation 0.02
|
0.70 mg/dL
Standard Deviation 0.04
|
0.74 mg/dL
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Immunoglobulins (IgA) From Baseline to 90 Days
Baseline IgA
|
200.91 g/dL
Standard Deviation 0.66
|
214.75 g/dL
Standard Deviation 1.39
|
210.56 g/dL
Standard Deviation 1.26
|
204.54 g/dL
Standard Deviation 1.31
|
199.97 g/dL
Standard Deviation 1.34
|
|
Change in Immunoglobulins (IgA) From Baseline to 90 Days
30 days IgA
|
201.09 g/dL
Standard Deviation 0.98
|
212.33 g/dL
Standard Deviation 1.82
|
207.42 g/dL
Standard Deviation 2.34
|
201.29 g/dL
Standard Deviation 2.95
|
194.84 g/dL
Standard Deviation 2.56
|
|
Change in Immunoglobulins (IgA) From Baseline to 90 Days
60 days IgA
|
198.97 g/dL
Standard Deviation 1.05
|
209.24 g/dL
Standard Deviation 2.06
|
203.48 g/dL
Standard Deviation 4.55
|
198.56 g/dL
Standard Deviation 2.99
|
191.90 g/dL
Standard Deviation 3.65
|
|
Change in Immunoglobulins (IgA) From Baseline to 90 Days
90 days IgA
|
196.23 g/dL
Standard Deviation 1.20
|
205.58 g/dL
Standard Deviation 2.75
|
200.37 g/dL
Standard Deviation 4.67
|
195.68 g/dL
Standard Deviation 3.22
|
186.22 g/dL
Standard Deviation 3.65
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Immunoglobulins (IgE) From Baseline to 90 Days
Baseline IgE
|
195.02 IU/mL
Standard Deviation 1.06
|
184.86 IU/mL
Standard Deviation 1.14
|
186.02 IU/mL
Standard Deviation 2.81
|
174.62 IU/mL
Standard Deviation 1.59
|
193.76 IU/mL
Standard Deviation 1.49
|
|
Change in Immunoglobulins (IgE) From Baseline to 90 Days
30 days IgE
|
192.59 IU/mL
Standard Deviation 1.34
|
181.87 IU/mL
Standard Deviation 2.19
|
182.36 IU/mL
Standard Deviation 3.44
|
171.73 IU/mL
Standard Deviation 2.63
|
189.69 IU/mL
Standard Deviation 2.47
|
|
Change in Immunoglobulins (IgE) From Baseline to 90 Days
60 days IgE
|
190.81 IU/mL
Standard Deviation 1.32
|
179.00 IU/mL
Standard Deviation 2.63
|
178.23 IU/mL
Standard Deviation 3.79
|
168.62 IU/mL
Standard Deviation 3.31
|
185.56 IU/mL
Standard Deviation 2.83
|
|
Change in Immunoglobulins (IgE) From Baseline to 90 Days
90 days IgE
|
187.32 IU/mL
Standard Deviation 1.39
|
176.28 IU/mL
Standard Deviation 3.49
|
174.09 IU/mL
Standard Deviation 3.50
|
164.60 IU/mL
Standard Deviation 3.98
|
177.73 IU/mL
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Immunoglobulins (IgG) From Baseline to 90 Days
90 days IgG
|
1674.86 g/dL
Standard Deviation 1.86
|
1700.06 g/dL
Standard Deviation 6.47
|
1711.76 g/dL
Standard Deviation 4.32
|
1678.98 g/dL
Standard Deviation 5.66
|
1622.73 g/dL
Standard Deviation 2.45
|
|
Change in Immunoglobulins (IgG) From Baseline to 90 Days
Baseline IgG
|
1684.10 g/dL
Standard Deviation 2.39
|
1718.47 g/dL
Standard Deviation 3.49
|
1734.16 g/dL
Standard Deviation 2.61
|
1691.93 g/dL
Standard Deviation 2.76
|
1707.56 g/dL
Standard Deviation 2.14
|
|
Change in Immunoglobulins (IgG) From Baseline to 90 Days
30 days IgG
|
1681.23 g/dL
Standard Deviation 2.12
|
1708.98 g/dL
Standard Deviation 5.18
|
1727.20 g/dL
Standard Deviation 3.66
|
1687.67 g/dL
Standard Deviation 3.06
|
1684.95 g/dL
Standard Deviation 2.32
|
|
Change in Immunoglobulins (IgG) From Baseline to 90 Days
60 days IgG
|
1678.54 g/dL
Standard Deviation 2.46
|
1704.64 g/dL
Standard Deviation 5.80
|
1719.79 g/dL
Standard Deviation 4.51
|
1682.53 g/dL
Standard Deviation 4.26
|
1655.01 g/dL
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 90 daysOutcome measures
| Measure |
Placebo Only
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt FeSO4
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic Inulin & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
Prebiotic GOS & Iron Salt NaFeEDTA
n=15 Participants
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
|
|---|---|---|---|---|---|
|
Change in Immunoglobulins (IgM) From Baseline to 90 Days
Baseline IgM
|
303.66 g/dL
Standard Deviation 2.51
|
285.20 g/dL
Standard Deviation 2.57
|
273.74 g/dL
Standard Deviation 2.20
|
267.76 g/dL
Standard Deviation 3.05
|
256.37 g/dL
Standard Deviation 1.69
|
|
Change in Immunoglobulins (IgM) From Baseline to 90 Days
30 days IgM
|
300.55 g/dL
Standard Deviation 2.51
|
281.25 g/dL
Standard Deviation 2.36
|
271.15 g/dL
Standard Deviation 2.31
|
264.41 g/dL
Standard Deviation 3.05
|
234.41 g/dL
Standard Deviation 1.87
|
|
Change in Immunoglobulins (IgM) From Baseline to 90 Days
60 days IgM
|
299.38 g/dL
Standard Deviation 2.51
|
278.21 g/dL
Standard Deviation 2.59
|
267.81 g/dL
Standard Deviation 2.83
|
259.83 g/dL
Standard Deviation 3.23
|
213.71 g/dL
Standard Deviation 2.28
|
|
Change in Immunoglobulins (IgM) From Baseline to 90 Days
90 days IgM
|
296.90 g/dL
Standard Deviation 2.51
|
271.64 g/dL
Standard Deviation 2.93
|
264.02 g/dL
Standard Deviation 3.15
|
256.95 g/dL
Standard Deviation 3.16
|
203.21 g/dL
Standard Deviation 3.43
|
Adverse Events
Placebo Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prebiotic Inulin & Iron Salt NaFeEDTA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prebiotic Inulin & Iron Salt NaFeEDTA (2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prebiotic Inulin & Iron Salt FeS04
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prebiotic GOS & Iron Salt NaFeEDTA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Waqas Ahmed
University of Veterinary & Animal Sciences, Lahore, Pakistan
Phone: 0092-42-99211449
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The research is the property of the University and we have signed an Intellectual Property Rights agreement whereby we will not disclose the study results.
- Publication restrictions are in place
Restriction type: OTHER