Trial Outcomes & Findings for Antioxidant Supplementation in Pregnant Women (NCT NCT01232205)

Results Overview

Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \[Korotkoff V\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\> 0.3 g/day). Severe preeclampsia was defined by the presence of \>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

168 participants

Primary outcome timeframe

40 weeks

Results posted on

2010-12-02

Participant Flow

Recruitment started in June 2001 and completed in December 2009, Department of Obstetrics and Gynaecology, University of Indonesia, at Cipto Mangunkusumo National Hospital

There were 110 (65.4 percent) eligible subjects from 168 pregnant women, because of ferric reducing ability of plasma (FRAP) level measured

Participant milestones

Participant milestones
Measure	Micronutrient Antioxidant Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium	Control
Overall Study STARTED	52	58
Overall Study COMPLETED	49	55
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antioxidant Supplementation in Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Micronutrient Antioxidant n=52 Participants Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium	Control n=58 Participants	Total n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	58 Participants n=7 Participants	110 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	28.1 years STANDARD_DEVIATION 5.08 • n=5 Participants	29.7 years STANDARD_DEVIATION 5.07 • n=7 Participants	28.9 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	58 Participants n=7 Participants	110 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Indonesia	52 participants n=5 Participants	58 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 40 weeks

Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \[Korotkoff V\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\> 0.3 g/day). Severe preeclampsia was defined by the presence of \>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 9 months

Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \[Korotkoff V\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\> 0.3 g/day). Severe preeclampsia was defined by the presence of \>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)

Outcome measures

Outcome measures
Measure	Micronutrient Antioxidant n=52 Participants Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium	Control n=58 Participants
Preeclampsia	1 participants	8 participants

SECONDARY outcome

Timeframe: 40 weeks

Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))

Outcome measures

Outcome data not reported

Adverse Events

Micronutrient Antioxidant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Yuditiya Purwosunu

Dept Obstetrics Gynecology Indonesia University

Phone: +44 753 870 6897

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place