Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
228 participants
INTERVENTIONAL
2013-11-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Control Group
Subjects in the control group will continue to take the prenatal supplement primarily consisting of folic acid (400 mcg), elemental iron (60 mg) and will receive breastfeeding advice during prenatal visits.
No interventions assigned to this group
Intervention
Lactation support in conjunction with a maternal nutritional supplement S348S0
Maternal Nutritional Supplement
S348S0
Interventions
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Maternal Nutritional Supplement
S348S0
Eligibility Criteria
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Inclusion Criteria
2. Mother is between 20 and 35 years of age.
3. Mother pre-pregnant BMI \< 25.0 kg/m2.
4. Mother is first-time mother.
5. Mother is contactable by telephone.
6. Mother is non-smoker.
7. Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
8. Infant's birth weight was \> 2500 g.
9. Infant is judged to be in good health.
10. Mother confirms her intention to breastfeed and refrain from taking any other nonstudy maternal milk supplement or galactogogues during the study period.
Exclusion Criteria
2. An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development.
3. Mother has gestational diabetes and/or pre-eclampsia.
4. Mother with contraindications to breastfeeding.
5. Gestational weight gain is greater than 14 kg at enrollment.
6. Mother had a breast surgery.
7. Mother and/or newborn infant has major illness that requires intensive care admission.
8. Infant has major congenital anomaly.
20 Years
35 Years
FEMALE
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Dieu Huynh, MD, PhD.
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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An Lao District Health Center - Bat Trang
Haiphong, , Vietnam
An Lao District Health Center - Quoc Tuan
Haiphong, , Vietnam
An Lao District Health Center - Thai Son
Haiphong, , Vietnam
An Lao District Health Centre- Quoc Trung
Haiphong, , Vietnam
An Lao District Health Centre- Truang Tho
Haiphong, , Vietnam
Bin Luc District Health Centre- Dong Du
Hà Nam, , Vietnam
Binh Luc District Health Center - An Lao
Hà Nam, , Vietnam
Binh Luc District Health Center - Binh Nghia
Hà Nam, , Vietnam
Binh Luc District Health Center - Trang An
Hà Nam, , Vietnam
Yen Mo District Health Center - Yen Dong
Ninh Bình, , Vietnam
Yen Mo District Health Center - Yen Hoa
Ninh Bình, , Vietnam
Yen Mo District Health Center - Yen Thanh
Ninh Bình, , Vietnam
Phu Binh District Health Center - Kha Son
Thái Nguyên, , Vietnam
Phu Binh District Health Center - Tan Khanh
Thái Nguyên, , Vietnam
Phu Binh District Health Center - Tan Kim
Thái Nguyên, , Vietnam
Phu Binh District Health Centre- Tan Duc
Thái Nguyên, , Vietnam
Phu Binh District Health Centre- Tan Hoa
Thái Nguyên, , Vietnam
Phu Binh District Health Centre- Xuan Phuong
Thái Nguyên, , Vietnam
Countries
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References
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Tran NT, Nguyen LT, Berde Y, Low YL, Tey SL, Huynh DTT. Maternal nutritional adequacy and gestational weight gain and their associations with birth outcomes among Vietnamese women. BMC Pregnancy Childbirth. 2019 Dec 4;19(1):468. doi: 10.1186/s12884-019-2643-6.
Other Identifiers
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AL08
Identifier Type: -
Identifier Source: org_study_id
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