NCT00719160

Brief Summary

We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric acid secretion explain the observed changes in intestinal calcium absorption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2005

Typical duration for phase_4

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, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

January 4, 2013

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

July 17, 2008

Results QC Date

January 26, 2012

Last Update Submit

March 4, 2020

Conditions

Osteoporosis

Keywords

Gastric acidDietary proteinCalciumIntestinal absorptionCalcium sensing receptor

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Intestinal Calcium Absorption

    This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.

    Day 5 of a high protein diet

Secondary Outcomes (1)

  • Gastric pH

    Day 5 of a high protein diet

Study Arms (2)

Esomeprazole

PLACEBO COMPARATOR
Drug: esomeprazoleDrug: Placebo

Placebo

ACTIVE COMPARATOR
Drug: esomeprazoleDrug: Placebo

Interventions

esomeprazoleDRUG

2 Interventions with esomeprazole 20 mg twice a day for 9 days vs. a placebo for 9 days while on a high protein diet

EsomeprazolePlacebo
PlaceboDRUG

Placebo 20 mg twice a day for 9 days

EsomeprazolePlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women age 18-45 years
  • Caucasian or Asian descent due to increased risk of Osteoporosis

You may not qualify if:

  • gastrointestinal diseases
  • osteoporosis
  • diabetes
  • hypertension
  • liver disease
  • thyroid disorders
  • kidney disease
  • kidney stones
  • cancer
  • heart disease
  • eating disorders
  • obesity
  • hypogonadism
  • amenorrhea
  • oligomenorrhea
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital Hospital Research Unit

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Karl L. Insogna, M.D.
Organization
Yale University
Karl.insogna@yale.edu
203-737-2871

Study Officials

  • Karl Insogna, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

January 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 6, 2020

Results First Posted

January 4, 2013

Record last verified: 2020-03

Locations

US(1)