Study to Observe the Capability to Absorb Calcium as an Measure of Adequate Levels of Vitamin D

NCT01119378 | Completed

• 1 other identifier: 10003
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the capability to absorb calcium as a measure of the sufficient levels of Vitamin D. Calcium absorption will be measured at baseline and after vitamin D3, by dual calcium isotope technique using stable isotopes in post menopausal women between the ages 50 and 70yrs. Subjects will have a screening visit, first and final visits. Subjects will be randomly assigned to a placebo or daily doses of vitamin D3. The specific aim of this study is to determine the level of vitamin D that will maximize the absorption of calcium and establish the relationship between the administered calcium dose and the actual absorbed calcium dose versus administered dose of Vitamin D and the serum levels of Vitamin D.

Conditions

Postmenopausal; Vitamin D Deficiency

Keywords

Post menopausal; Vitamin D sufficiency; Calcium absorption efficiency; Dual isotope technique

Outcome Measures

Primary Outcomes (1)

• To determine the level of 25OHD that maximizes calcium absorption efficiency.

  3 months

Secondary Outcomes (1)

• To describe the dose response curve of calcium absorption to vitamin D intake and serum 25OHD

  3 months

Study Arms (1)

Post Menopausal

EXPERIMENTAL

post menopausal women between the ages 50-70 yrs.

Other: Dual isotope technique

Interventions

Dual isotope technique OTHER

Dual isotope technique using stable isotopes

Also known as: Kinetic study, dual stable isotope

Post Menopausal

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post menopausal women between the ages 50-70 yrs.

You may not qualify if:

• Any chronic medical illness including diabetes mellitus, history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
• Subjects with a BMI \>35kg/m2
• Use of medication that influences vitamin D and bone metabolism (i.e. anticonvulsant medications, glucocorticoids, HAART \[AIDS treatment\], antirejection medications, high dose diuretics etc).
• Significant deviation from normal either in history, physical examination, or laboratory tests as evaluated by the primary investigator.
• Patients with a history of hypercalciuria ( Urine calcium:creatinine ratio \> 0.37 , hypercalcemia ( serum calcium \>10.21, nephrolithiasis, and active sarcoidosis will also be excluded.
• Unexplained weight loss \>15% during the previous year or history of anorexia nervosa
• Participation in another investigational trial in the past 30 days prior to the screening evaluation.
• Patients reporting alcohol intake greater than 2 drinks daily.
• Subjects with baseline 25-OHD level greater than 70 nmol /L will be excluded.
• Smokers greater than one pack per day will be excluded
• Dietary calcium intake greater than 2000 mg will be excluded
• Participants who have history of allergy to milk, gluten or orange juice will be excluded
• Participants willing not to forego multivitamins and vitamin D supplements during the study -

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (1)

• Aloia JF, Dhaliwal R, Shieh A, Mikhail M, Fazzari M, Ragolia L, Abrams SA. Vitamin D supplementation increases calcium absorption without a threshold effect. Am J Clin Nutr. 2014 Mar;99(3):624-31. doi: 10.3945/ajcn.113.067199. Epub 2013 Dec 11.

  PMID: 24335055 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• John F Aloia, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

US (1)