Trial Outcomes & Findings for Iron Bioavailability of Fortified Oat Drink (NCT NCT01423162)
NCT ID: NCT01423162
Last Updated: 2012-09-21
Results Overview
Percentage of iron available for absorption from fortified oat drink with and without added vitamin C
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
14 days after administration
Results posted on
2012-09-21
Participant Flow
Recruitment took place in August 2011
One subject was excluded prior to group assignment due to illness
Participant milestones
| Measure |
Drink With Vit C Then Drink Without Vit C
Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
|
Drink Without Vitamin C Then Drink With Vit C
Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Iron Bioavailability of Fortified Oat Drink
Baseline characteristics by cohort
| Measure |
Drink With Vit C Then Drink Without Vit C
n=11 Participants
Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C
|
Drink Without Vit C Then Drink With Vit C
n=9 Participants
Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
years
|
6.3 years
n=93 Participants
|
6.4 years
n=4 Participants
|
6.3 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
Philippines
|
11 participants
n=93 Participants
|
9 participants
n=4 Participants
|
20 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 14 days after administrationPopulation: Per protocol
Percentage of iron available for absorption from fortified oat drink with and without added vitamin C
Outcome measures
| Measure |
Fortified Oat Drink With Vitamin C
n=19 Participants
|
Fortified Oat Drink Without Vitamin C
n=19 Participants
|
|---|---|---|
|
Percent Iron Absorption
|
7.14 percentage of Iron absorbed
Standard Error 0.90
|
5.65 percentage of Iron absorbed
Standard Error 0.54
|
Adverse Events
Drink With Vit C Then Drink Without Vit C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Drink Without Vitamin C Then Drink With Vit C
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
Trinidad P. Trinidad
Food and Nutrition Research Institute
Phone: 6328372071
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 18 months from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER