Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
Hamisu Salihu, University of South Florida
ClinicalTrials.gov Identifier:
NCT01248260
First received: November 10, 2010
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Fetal Body Size
Fetal Brain Size
Dietary Supplement: Folic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Fetal Body Size [ Time Frame: Participants will be followed from baseline (first trimester) until delivery ] [ Designated as safety issue: No ]
    Low birth weight will be defined as birth weight less than 2500g; Small for gestational age will be defined as birth weight in the lowest 10th percentile; The fetal growth ratio will be expressed as the ratio of the observed birth weight to the expected mean birth weight for each gestational age.

  • Fetal Brain Size [ Time Frame: Participants will be followed from baseline (first trimester) until delivery ] [ Designated as safety issue: No ]
    Head Circumference at birth: will be measured at birth as routinely performed at the study site. Observed: Expected head circumference ratio: This is the ratio between the actual head circumference and the expected head circumference according to gestational age (this could also be expressed in terms of percentage of expected head circumference). Brain weight: will be estimated from formula: brain weight (g) = 0.037 X head circumference (cm)2.57. Brain-to-body ratio (BBR): The BBR is defined as 100 the ratio of the infant's estimated brain weight to its birth weight.


Secondary Outcome Measures:
  • Preterm Birth [ Time Frame: Participants will be followed from baseline (first trimester) until delivery ] [ Designated as safety issue: No ]
    This is defined as live birth after 20 weeks of gestation but before 37 completed weeks. Genetic and Epigenetic Markers of Fetal Brain Growth and Development: Cord blood obtained at delivery will be analyzed for selected regulatory genes.


Estimated Enrollment: 330
Study Start Date: February 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Higher-strength folic acid
Higher-strength folic acid (4mg).
Dietary Supplement: Folic Acid
4mg of higher strength folic acid once a day until delivery
No Intervention: Low-strength folic acid
Low-strength (0.8mg) folic acid (standard of care)

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248260

Contacts
Contact: Hamisu M Salihu, MD, PhD 205-910-8720 hsalihu@health.usf.edu
Contact: Lindsey M King, MPH 813-974-3730 LKing1@health.usf.edu

Locations
United States, Florida
University of South Florida, College of Public Health, Department of Epidemiology and Biostatistics Recruiting
Tampa, Florida, United States, 33612
Contact: Hamisu M Salihu, MD, PhD    205-910-8720    hsalihu@health.usf.edu   
Contact: Lindsey M King, MPH, CHES    813-974-3730    LKing1@health.usf.edu   
Sponsors and Collaborators
Hamisu Salihu
Investigators
Principal Investigator: Hamisu M Salihu, MD, PhD University of South Florida
  More Information

No publications provided

Responsible Party: Hamisu Salihu, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01248260     History of Changes
Other Study ID Numbers: 1KG14
Study First Received: November 10, 2010
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Fetal body size
Fetal brain size
Folic acid

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014