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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Winthrop University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01119378
First received: May 5, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Postmenopausal
Vitamin D Deficiency
Other: Dual isotope technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Calcium Absorption Efficiency As An Indicator For Vitamin D Sufficiency

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • To determine the level of 25OHD that maximizes calcium absorption efficiency. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the dose response curve of calcium absorption to vitamin D intake and serum 25OHD [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: December 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post Menopausal
post menopausal women between the ages 50-70 yrs.
Other: Dual isotope technique
Dual isotope technique using stable isotopes
Other Names:
  • Kinetic study
  • dual stable isotope

Detailed Description:

The specific aims of this project are:

  1. To determine the level of 25OHD that maximizes calcium absorption efficiency.
  2. To describe the dose response curve of calcium absorption to vitamin D intake and serum 25OHD.

This will be a randomized, double-blind, placebo-controlled trial of healthy postmenopausal females to determine the individual and combined effects of calcium and vitamin D supplementation.70 female participants, ages 50 to 70 years of age who are menopausal for over 1 year will be recruited into the study . The patients participation in this study will last about 10 weeks. Approximately 70 subjects from Winthrop University Hospital and the surrounding area will participate in this study. There is a total of 3 visits. Patients will be fasting for all visits. The first visit is a screening visit to determine if the patients qualify.

At visit 2, the patients will be given a light breakfast and asked to drink an 8 ounce glass of milk or calcium fortified orange juice containing a calcium isotope. After breakfast, the doctor or nurse will start an intravenous infusion and inject the patient with an IV solution containing a calcium isotope. This is a stable calcium isotope that is not radioactive and has no known toxicity. The patients will also be asked to collect a 24 hour urine and return it to us the next day.

The volunteers will be divided into four groups:

The first group will take 800 iu daily of vitamin D supplementation. The second group will take 2000 iu daily of vitamin D.The third group will take 4000 iu vitamin D and the fourth group will only take placebos. Visit 3 is essentially the same as visit 2, with subjects returning unused study medication and given new tablets

Food frequency questionnaires will be filled out at the initial visit and final visit. Diet will be assessed using 3-day diet history form and NutritionPro analysis software. Patients will be asked to refrain from taking other vitamin D supplements and to continue their usual calcium intake.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Post menopausal women between the ages 50-70 yrs.

Exclusion Criteria:

  1. 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.
  2. Subjects with a BMI >35kg/m2
  3. Use of medication that influences vitamin D and bone metabolism (i.e. anticonvulsant medications, glucocorticoids, HAART [AIDS treatment], antirejection medications, high dose diuretics etc).
  4. Significant deviation from normal either in history, physical examination, or laboratory tests as evaluated by the primary investigator.
  5. 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.
  6. Unexplained weight loss >15% during the previous year or history of anorexia nervosa
  7. Participation in another investigational trial in the past 30 days prior to the screening evaluation.
  8. Patients reporting alcohol intake greater than 2 drinks daily.
  9. Subjects with baseline 25-OHD level greater than 70 nmol /L will be excluded.
  10. Smokers greater than one pack per day will be excluded
  11. Dietary calcium intake greater than 2000 mg will be excluded
  12. Participants who have history of allergy to milk, gluten or orange juice will be excluded
  13. Participants willing not to forego multivitamins and vitamin D supplements during the study -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119378

Contacts
Contact: John F Aloia, MD 516-663-8793 jaloia@winthrop.org
Contact: Mageda Mikhail, MD 516-663-8793 MMikhail@Winthrop.org

Locations
United States, New York
Winthrop University Hospital Not yet recruiting
Mineola, New York, United States, 11501
Sub-Investigator: Mageda Mikhail, MD         
Sub-Investigator: James Yeh, MD         
Sub-Investigator: Padma Gadde, MD,MPH         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: John F Aloia, MD Winthrop University Hospital
  More Information

No publications provided by Winthrop University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John F. Aloia, M.D. Principal Investigator:, Winthrop-University Hospital
ClinicalTrials.gov Identifier: NCT01119378     History of Changes
Other Study ID Numbers: 10003
Study First Received: May 5, 2010
Last Updated: May 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Post menopausal
Vitamin D sufficiency
Calcium absorption efficiency
Dual isotope technique

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014