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

NCT02536352 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB00038838
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fluoride Supplementation; Prenatal Vitamin; Pregnancy Nutrition; Prenatal Nutrition

Outcome Measures

Primary Outcomes (1)

• Length of gestation

  the length of gestation will be measured in weeks at time of delivery

  Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study

Secondary Outcomes (4)

• Birth weight

  Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study

• Birth length

  Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study

• Preterm birth

  Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study

• Preterm premature rupture of membranes (PPROM)

  Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study

Study Arms (2)

Fluoride prenatal vitamin

EXPERIMENTAL

Prenatal vitamin-mineral containing 3 mg fluoride

Drug: Prenatal vitamin-mineral containing 3 mg fluoride

Standard prenatal vitamin

ACTIVE COMPARATOR

Prenatal vitamin-mineral containing 0 mg fluoride

Dietary Supplement: Prenatal vitamin-mineral containing 0 mg fluoride

Interventions

Prenatal vitamin-mineral containing 3 mg fluoride DRUG

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

Fluoride prenatal vitamin

Prenatal vitamin-mineral containing 0 mg fluoride DIETARY_SUPPLEMENT

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

Standard prenatal vitamin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who are between 10-20 weeks gestational age at the time of recruitment
• Delivery at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center

You may not qualify if:

• Use of prescription strength, high dose fluoride products (greater than 0.76% of fluoride), prescribed by a dental professional (toothpastes, mouthwashes, topical treatments). All over-the-counter toothpaste and mouthwash products are acceptable to use.
• Occupational exposure to fluoride.
• The daily amount of fluoride ingested should not exceed 10 mg/day, according to the Institute of Medicine and the FDA. Any participants consuming amounts of fluoride close to 10 mg/day will be excluded.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• Leverett DH, Adair SM, Vaughan BW, Proskin HM, Moss ME. Randomized clinical trial of the effect of prenatal fluoride supplements in preventing dental caries. Caries Res. 1997;31(3):174-9. doi: 10.1159/000262394.

  PMID: 9165186 BACKGROUND

• Srinivas SK, Sammel MD, Stamilio DM, Clothier B, Jeffcoat MK, Parry S, Macones GA, Elovitz MA, Metlay J. Periodontal disease and adverse pregnancy outcomes: is there an association? Am J Obstet Gynecol. 2009 May;200(5):497.e1-8. doi: 10.1016/j.ajog.2009.03.003.

  PMID: 19375568 BACKGROUND

• Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK109825/

  PMID: 23115811 BACKGROUND

• Iheozor-Ejiofor Z, Middleton P, Esposito M, Glenny AM. Treating periodontal disease for preventing adverse birth outcomes in pregnant women. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD005297. doi: 10.1002/14651858.CD005297.pub3.

  PMID: 28605006 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Bacteremia; Fetal Membranes, Premature Rupture

Interventions

Fluorides

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• Irina Burd, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: August 31, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

US (1)