Trial Outcomes & Findings for A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh (NCT NCT01749982)
NCT ID: NCT01749982
Last Updated: 2014-08-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Results posted on
2014-08-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablets
Placebo
|
Choline Bitartrate
Choline bitartrate 700 mg by mouth daily
Choline bitartrate
|
Betaine
Betaine 1000 mg by mouth daily
Betaine
|
Choline Bitartrate + Betaine
Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablets
Placebo
|
Choline Bitartrate
Choline bitartrate 700 mg by mouth daily
Choline bitartrate
|
Betaine
Betaine 1000 mg by mouth daily
Betaine
|
Choline Bitartrate + Betaine
Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Placebo tablets
Placebo
|
Choline Bitartrate
n=15 Participants
Choline bitartrate 700 mg by mouth daily
Choline bitartrate
|
Betaine
n=15 Participants
Betaine 1000 mg by mouth daily
Betaine
|
Choline Bitartrate + Betaine
n=15 Participants
Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
30.0 years
n=99 Participants
|
34.0 years
n=107 Participants
|
29.0 years
n=206 Participants
|
32.0 years
n=7 Participants
|
31.0 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Bangladesh
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
15 participants
n=206 Participants
|
15 participants
n=7 Participants
|
60 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo tablets
Placebo
|
Choline Bitartrate
n=15 Participants
Choline bitartrate 700 mg by mouth daily
Choline bitartrate
|
Betaine
n=15 Participants
Betaine 1000 mg by mouth daily
Betaine
|
Choline Bitartrate + Betaine
n=12 Participants
Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine
|
|---|---|---|---|---|
|
Change in Urinary % Monomethyl Arsenic
|
2.4 percentage of total urinary arsenic
Interval -8.4 to 7.8
|
0.24 percentage of total urinary arsenic
Interval -4.3 to 9.4
|
-0.06 percentage of total urinary arsenic
Interval -11.6 to 5.4
|
-3.2 percentage of total urinary arsenic
Interval -8.9 to 1.2
|
PRIMARY outcome
Timeframe: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo tablets
Placebo
|
Choline Bitartrate
n=15 Participants
Choline bitartrate 700 mg by mouth daily
Choline bitartrate
|
Betaine
n=15 Participants
Betaine 1000 mg by mouth daily
Betaine
|
Choline Bitartrate + Betaine
n=12 Participants
Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine
|
|---|---|---|---|---|
|
Change in Urinary % Inorganic Arsenic
|
3.0 percentage of total urinary arsenic
Interval -13.2 to 10.3
|
-0.87 percentage of total urinary arsenic
Interval -21.7 to 20.8
|
-1.25 percentage of total urinary arsenic
Interval -8.2 to 8.2
|
-1.7 percentage of total urinary arsenic
Interval -12.7 to 26.7
|
PRIMARY outcome
Timeframe: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo tablets
Placebo
|
Choline Bitartrate
n=15 Participants
Choline bitartrate 700 mg by mouth daily
Choline bitartrate
|
Betaine
n=15 Participants
Betaine 1000 mg by mouth daily
Betaine
|
Choline Bitartrate + Betaine
n=12 Participants
Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine
|
|---|---|---|---|---|
|
Change in Urinary % Dimethyl Arsenic
|
-5.8 percentage of total urinary arsenic
Interval -11.5 to 21.6
|
0.65 percentage of total urinary arsenic
Interval -16.4 to 15.3
|
-0.87 percentage of total urinary arsenic
Interval -13.4 to 13.9
|
5.45 percentage of total urinary arsenic
Interval -20.8 to 18.5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Choline Bitartrate
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Betaine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Choline Bitartrate + Betaine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Placebo tablets
Placebo
|
Choline Bitartrate
n=15 participants at risk
Choline bitartrate 700 mg by mouth daily
Choline bitartrate
|
Betaine
n=15 participants at risk
Betaine 1000 mg by mouth daily
Betaine
|
Choline Bitartrate + Betaine
n=15 participants at risk
Choline bitartrate 700 mg + Betaine 1000 mg daily
Choline bitartrate + Betaine
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15
|
13.3%
2/15
|
0.00%
0/15
|
13.3%
2/15
|
|
General disorders
Fever
|
20.0%
3/15
|
13.3%
2/15
|
13.3%
2/15
|
0.00%
0/15
|
|
General disorders
Chest pain
|
0.00%
0/15
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place