Iowa Fluoride Study/Iowa Bone Development Study NCT03547128

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number	NCT03547128
Other study ID #	199112665
Secondary ID
Status	Active, not recruiting
Phase
First received
Last updated
Start date	March 1, 1992
Est. completion date	January 15, 2025

Study information
Verified date	February 2024
Source	University of Iowa
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

A cohort of newborns was recruited for the Iowa Fluoride Study from 1992-95 to assess the complex relationships among fluoride intakes, fluoride exposures, dental fluorosis, and dental caries. Detailed questionnaires were sent every 1.5-6 months concerning water sources, fluoride exposures, dietary intakes, etc. Standardized dental exams were conducted at ~ages 5, 9, 13, 17, and 23. At about age 5, participants were invited to join the offshoot Iowa Bone Development Study. Bone densitometry assessments were conducted at ages 5, 8, 11, 13, 15, 17, 19, and 23. These included Dual-energy X-ray Absorptiometry (DXA) of hip, lumbar spine, and whole body from age 5; peripheral Quantitative Computed Tomography (pQCT) of the radius and tibia from age 11; and Multi-Detector Computed Tomography (MDCT) of the tibia from age 19. Physical activity and other factors also were assessed longitudinally.

Description:

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	1882
Est. completion date	January 15, 2025
Est. primary completion date	March 1, 1996
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	1 Month to 30 Years
Eligibility	Inclusion Criteria: - healthy newborn Exclusion Criteria: - not health newborn

Study Design

Related Conditions & MeSH terms

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Steven M Levy

Outcome
Type	Measure	Description	Time frame
Primary	dental fluorosis-5	dental fluorosis exam results	age 5
Primary	dental fluorosis-9	dental fluorosis exam results	age 9
Primary	dental fluorosis-13	dental fluorosis exam results	age 13
Primary	dental fluorosis-17	dental fluorosis exam results	age 17
Primary	dental fluorosis-23	dental fluorosis exam results	age 23
Primary	dental caries-5	dental caries exam results	age 5
Primary	dental caries-9	dental caries exam results	age 5
Primary	dental caries-13	dental caries exam results	age 9
Primary	dental caries-17	dental caries exam results	age 17
Primary	dental caries-23	dental caries exam results	age 23
Primary	bone densitometry-5	DXA scans	age 5
Primary	bone densitometry-8	DXA scans	age 8
Primary	bone densitometry-11	DXA and pQCT scans	age 11
Primary	bone densitometry-13	DXA and pQCT scans	age 13
Primary	bone densitometry-15	DXA and pQCT scans	age 15
Primary	bone densitometry-17	DXA and pQCT scans	age 17
Primary	bone densitometry-19	DXA, pQCT, and MDCT scans	age 19
Primary	bone densitometry-23	DXA, pQCT, and MDCT scans	age 23

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Iowa Fluoride Study/Iowa Bone Development Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Locations

Sponsors (1)

Outcome