NCT01248260

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

5.5 years

First QC Date

November 10, 2010

Last Update Submit

February 13, 2019

Conditions

Fetal Body SizeFetal Brain Size

Keywords

Fetal body sizeFetal brain sizeFolic acid

Outcome Measures

Primary Outcomes (2)

  • Fetal Body Size

    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.

    Participants will be followed from baseline (first trimester) until delivery

  • Fetal Brain Size

    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.

    Participants will be followed from baseline (first trimester) until delivery

Secondary Outcomes (1)

  • Preterm Birth

    Participants will be followed from baseline (first trimester) until delivery

Study Arms (2)

Higher-strength folic acid

EXPERIMENTAL

Higher-strength folic acid (4mg).

Dietary Supplement: Folic Acid

Low-strength folic acid

NO INTERVENTION

Low-strength (0.8mg) folic acid (standard of care)

Interventions

Folic AcidDIETARY_SUPPLEMENT

4mg of higher strength folic acid once a day until delivery

Higher-strength folic acid

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ((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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida, College of Public Health, Department of Epidemiology and Biostatistics

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • Yusuf KK, Salihu HM, Wilson R, Mbah A, Sappenfield W, Bruder K, Wudil UJ, Aliyu MH. Folic Acid Intake, Fetal Brain Growth, and Maternal Smoking in Pregnancy: A Randomized Controlled Trial. Curr Dev Nutr. 2019 Apr 4;3(6):nzz025. doi: 10.1093/cdn/nzz025. eCollection 2019 Jun.

    PMID: 31139766DERIVED

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hamisu M Salihu, MD, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 25, 2010

Study Start

February 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

US(1)