This trial is active, not recruiting.

Conditions fetal body size, fetal brain size
Treatment folic acid
Sponsor Hamisu Salihu
Start date February 2011
End date August 2016
Trial size 450 participants
Trial identifier NCT01248260, 1KG14


The purpose of this study is to find out if folic acid prevents of the reduction of fetal body and brain size in infants whose mothers smoke.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Higher-strength folic acid (4mg).
folic acid
4mg of higher strength folic acid once a day until delivery
(No Intervention)
Low-strength (0.8mg) folic acid (standard of care)

Primary Outcomes

Fetal Body Size
time frame: Participants will be followed from baseline (first trimester) until delivery
Fetal Brain Size
time frame: Participants will be followed from baseline (first trimester) until delivery

Secondary Outcomes

Preterm Birth
time frame: Participants will be followed from baseline (first trimester) until delivery

Eligibility Criteria

Female participants from 18 years up to 44 years old.

Inclusion Criteria: ((1) Smoker, based on presence of detectable cotinine in saliva (biomarker).; (2) Ages 18-44 years; (3) Singleton gestation (< 20 weeks), confirmed by sonogram; (4) Residents of Tampa, Florida or surrounding area in order to facilitate follow-up and reduce attrition rate. Exclusion Criteria: (a) an indication for chronic blood transfusion. Women receiving chronic blood transfusions will not be enrolled, as transfused red blood cells (RBC) can result in inaccurate analysis of folate RBC levels88; (b) generalized seizure disorder treated with anti-convulsant medication: Patients with generalized seizure disorder treated with anticonvulsant medication will be excluded because of the potential association with folic acid deficiency88.

Additional Information

Official title Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
Principal investigator Hamisu M Salihu, MD, PhD
Description Smoking during pregnancy remains a common practice despite smoking cessation programs offered to mothers. Only 20-40% of women quit smoking during pregnancy which implies that a majority of smokers continue smoking despite the associated feto-infant morbidity and mortality. It is therefore important to identify ways and means of protecting these infants as they grow and develop during intrauterine life. In this study, we propose to assess the utility of higher-strength folic acid (4mg) combined with smoking cessation programs as compared to standard of care (smoking cessation program and low-strength (0.8mg) folic acid) in reducing the level of morbidity (specifically fetal body and brain size) sustained by infants of smokers
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of South Florida.