Trial Outcomes & Findings for Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children (NCT NCT01766310)

NCT ID: NCT01766310

Last Updated: 2015-12-11

Results Overview

Mean difference of changes of homocysteine level between 2 treatment groups

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2015-12-11

Participant Flow

Participant milestones

Measure	Placebo placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study placebo: sugar tablet manufactured to mimic folic acid tablet	Folic Acid Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study Folic Acid
Overall Study STARTED	24	26
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Placebo placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study placebo: sugar tablet manufactured to mimic folic acid tablet	Folic Acid Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study Folic Acid
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children

Baseline characteristics by cohort

Measure	Placebo n=24 Participants placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study placebo: sugar tablet manufactured to mimic folic acid tablet	Folic Acid n=26 Participants Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study Folic Acid	Total n=50 Participants Total of all reporting groups
Age, Continuous	10.73 years STANDARD_DEVIATION 1.64 • n=5 Participants	11.08 years STANDARD_DEVIATION 1.57 • n=7 Participants	10.90 years STANDARD_DEVIATION 1.60 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Mean difference of changes of homocysteine level between 2 treatment groups

Outcome measures

Measure	Placebo n=23 Participants placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study placebo: sugar tablet manufactured to mimic folic acid tablet	Folic Acid n=23 Participants Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study Folic Acid
Changes of Homocysteine Level	-0.68 µmol/L Standard Deviation 1.25	-1.35 µmol/L Standard Deviation 1.32

SECONDARY outcome

Timeframe: 8 weeks

correlation between serum folate and plasma homocysteine level

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

correlation between serum vitamin B12 and plasma homocysteine level

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

prevalence of hyperhomocysteinemia in Thai obese children

Outcome measures

Measure	Placebo n=24 Participants placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study placebo: sugar tablet manufactured to mimic folic acid tablet	Folic Acid n=26 Participants Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study Folic Acid
Prevalence of Hyperhomocysteinemia	3 participants	2 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Folic Acid

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. Orawan Iamopas

Queen Sirikit National Institute of Child Health

Phone: 66-2-354-8415

Email: orawaneamopas@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place