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Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being

NCT02536352 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-11-05

No results posted yet for this study

Summary

The purpose of this study is to determine whether fluoride supplementation during pregnancy is effective in extending the length of gestation and improving overall perinatal well-being.

Conditions

  • Preterm Birth
  • Preterm Labor
  • Bacteremia
  • Preterm Premature Rupture of Fetal Membranes

Interventions

DRUG

Prenatal vitamin-mineral containing 3 mg fluoride

Prenatal vitamin-mineral containing 3 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.

DIETARY_SUPPLEMENT

Prenatal vitamin-mineral containing 0 mg fluoride

Prenatal vitamin-mineral containing 0 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.

Sponsors & Collaborators

Principal Investigators

  • Irina Burd, M.D., Ph.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-10-01
Completion
2019-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02536352 on ClinicalTrials.gov