NCT01331265

Brief Summary

The goal of this study was to examine the effects of self-perceived lactose intolerance (SPLI) as it relates to calcium intake and specific health problems that have been attributed to reduced intake of calcium and foods from the dairy group in a nationally representative multi-ethnic sample of adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,815

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

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

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

April 6, 2011

Last Update Submit

January 13, 2020

Conditions

Lactose Intolerance

Keywords

perceived lactose intolerancecalcium/dairy consumptionspecific health outcomes

Study Arms (1)

no treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

white, black, and Hispanic adults; 18-50 years of age

You may qualify if:

  • adults between 18 and 50 years old

You may not qualify if:

  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Nicklas TA, Qu H, Hughes SO, Wagner SE, Foushee R, Shewchuk RM. Prevalence of Self-reported Lactose Intolerance in a Multi-ethnic Sample of Adults. Nutrition Today 44(5):222-227, 2009

    RESULT

  • Nicklas TA, Qu H, Hughes SO, He M, Wagner SE, Foushee HR, Shewchuk RM. Self-perceived lactose intolerance results in lower intakes of calcium and dairy foods and is associated with hypertension and diabetes in adults. Am J Clin Nutr. 2011 Jul;94(1):191-8. doi: 10.3945/ajcn.110.009860. Epub 2011 Apr 27.

    PMID: 21525197RESULT

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 8, 2011

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

US(1)