NCT01066806

Brief Summary

SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. . HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable obesity

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

July 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

5.2 years

First QC Date

January 19, 2010

Last Update Submit

September 21, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • percent change in body fat

    1 year

Study Arms (2)

high calcium diet

EXPERIMENTAL
Behavioral: counseling on increasing calcium intake

normal calcium diet

ACTIVE COMPARATOR
Other: observation

Interventions

counseling on increasing calcium intakeBEHAVIORAL

The American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day.

high calcium diet
observationOTHER

observe normal dairy intake

normal calcium diet

Eligibility Criteria

Age13 Years - 14 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 13-14 years old (must be this age when consent is signed)
  • Above the 50th percentile for BMI
  • Above the 85th percentile for BMI with approval from their primary physician
  • At least one and one- half years post menarche
  • Habitual dietary calcium intake of 600mg/d or less as assessed by 3 day diet diary. This will be inclusive of supplemental calcium and dietary intake.
  • Willingness to increase dietary calcium (low fat \[skim, 1%, 2%\] milk or yogurt) for one year

You may not qualify if:

  • Menarche prior to age 10
  • History of lactose intolerance or milk allergy
  • Weight \>300 pounds
  • BMI \> 97 percentile for age and gender
  • Pregnancy
  • Chronic disease or disorder like diabetes, polycystic ovarian syndrome, thyroid disease, seizures or cancer (cancer is ok if it has been \>10 years)
  • Use of steroids like prednisone, prednisolone, hydrocortisone, Flovent, Advair, or Nasonex
  • Use of weight reducing medications like Meredia, alli, Dexatrim or Xenical
  • Use of contraceptives like Yasmin, Ortho Tri-Cyclen, Apri, Aviane or Depo-Provera for any reason, including acne (see inclusive list)
  • Use of acne medications like Accutane or high dose Vitamin A
  • Use of ADHD medications like Adderall, Ritalin, Concerta. (Per Dr. Ramaswamy-Straterra OK) (see inclusive list)
  • Use of seizure medications like Lamictal or Phenobarb (see inclusive list)
  • Use of anti-depressants like Prozac or Effexor (see inclusive list)
  • Diagnosed eating disorder
  • Dieting behavior with weight loss \> 10 pounds in the last 3 months (IF YES, consult with Project Manager)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University Medical Center, Osteoporosis Research Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (1)

  • Lappe JM, McMahon DJ, Laughlin A, Hanson C, Desmangles JC, Begley M, Schwartz M. The effect of increasing dairy calcium intake of adolescent girls on changes in body fat and weight. Am J Clin Nutr. 2017 May;105(5):1046-1053. doi: 10.3945/ajcn.116.138941. Epub 2017 Mar 15.

    PMID: 28298396DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Observation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Joan M Lappe, PhD

    Creighton University, Osteoporosis Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 19, 2010

First Posted

February 10, 2010

Study Start

July 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

US(1)