Clinical trial NCT03547128: Iowa Fluoride Study/Iowa Bone Development Study
Official title: Iowa Fluoride Study/Iowa Bone Development Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Dental Fluoroses
Bone Density
Keywords: fluoride
genetics
physical activity
diet
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 1882
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns recruited from 8 Iowa hospitals postpartum

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* healthy newborn

Exclusion Criteria:

* not health newborn

Primary outcomes:
measure: dental fluorosis-5
timeFrame: age 5
measure: dental fluorosis-9
timeFrame: age 9
measure: dental fluorosis-13
timeFrame: age 13
measure: dental fluorosis-17
timeFrame: age 17
measure: dental fluorosis-23
timeFrame: age 23
measure: dental caries-5
timeFrame: age 5
measure: dental caries-9
timeFrame: age 5
measure: dental caries-13
timeFrame: age 9
measure: dental caries-17
timeFrame: age 17
measure: dental caries-23
timeFrame: age 23
measure: bone densitometry-5
timeFrame: age 5
measure: bone densitometry-8
timeFrame: age 8
measure: bone densitometry-11
timeFrame: age 11
measure: bone densitometry-13
timeFrame: age 13
measure: bone densitometry-15
timeFrame: age 15
measure: bone densitometry-17
timeFrame: age 17
measure: bone densitometry-19
timeFrame: age 19
measure: bone densitometry-23
timeFrame: age 23
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Steven M Levy, dds
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marshall TA, Curtis AM, Cavanaugh JE, Warren JJ, Levy SM. Beverage Intakes and Toothbrushing During Childhood Are Associated With Caries at Age 17 Years. J Acad Nutr Diet. 2021 Feb;121(2):253-260. doi: 10.1016/j.jand.2020.08.087. Epub 2020 Oct 24.
citation: Marshall TA, Curtis AM, Cavanaugh JE, Warren JJ, Levy SM. Child and Adolescent Sugar-Sweetened Beverage Intakes Are Longitudinally Associated with Higher Body Mass Index z Scores in a Birth Cohort Followed 17 Years. J Acad Nutr Diet. 2019 Mar;119(3):425-434. doi: 10.1016/j.jand.2018.11.003. Epub 2019 Jan 9.