Vitamin D Supplementation in Younger Women (VITADAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Nebraska
Information provided by (Responsible Party):
J.C. Gallagher, Creighton University
ClinicalTrials.gov Identifier:
NCT00662844
First received: April 17, 2008
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

That on average it will require a vitamin D dose of 1700IU/day to increase the serum 25hydroxyvitamin D level from 20 to 30ng/ml in young Caucasian women and a dose of 1860 to 2480 IU/day in African American


Condition Intervention
Hypovitaminosis D
Drug: vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Optimum Vitamin D Nutrition in Young Women

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Serum 25hydroxyvitamin D,parathyroid hormone [ Time Frame: Baseline, 6, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • serum and urine calcium [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: Yes ]
  • calcium absorption [ Time Frame: baseline and 12 month ] [ Designated as safety issue: No ]
    radioactive calcium absorption is measured at baseline and end of study

  • Bone density [ Time Frame: baseline and 12 month ] [ Designated as safety issue: No ]
    bone density

  • physical performance battery [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • Forced Expiratory Volume FEV1 [ Time Frame: baseline and 12 month ] [ Designated as safety issue: No ]
    spirometry

  • bone markers [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    serum osteocalcin,serum N-telopeptides

  • Serum 1,25-dihydroxyvitamin D3 [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    serum test

  • skin color [ Time Frame: baseline 6 and 12 month ] [ Designated as safety issue: No ]
    measurement of sin color through the study using an IMS smart probe


Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: May 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A1 vitamin D3 400IU
Orally for one year
Drug: vitamin D3
Oral, one capsule daily of vitamin D3 (400IU, 800IU, 1600 IU, or 2400IU) plus calcium citrate (1-4 tablets) twice daily to reach a total calcium intake of 1200-1400 mg/day
Other Name: Calcium citrate (Citracal)
Placebo Comparator: A2 vitamin D3 800IU
Orally for one year
Drug: vitamin D3
Oral, one capsule daily of vitamin D3 (400IU, 800IU, 1600 IU, or 2400IU) plus calcium citrate (1-4 tablets) twice daily to reach a total calcium intake of 1200-1400 mg/day
Other Name: Calcium citrate (Citracal)
Placebo Comparator: A3 vitamin D3 1600IU
Orally for one year
Drug: vitamin D3
Oral, one capsule daily of vitamin D3 (400IU, 800IU, 1600 IU, or 2400IU) plus calcium citrate (1-4 tablets) twice daily to reach a total calcium intake of 1200-1400 mg/day
Other Name: Calcium citrate (Citracal)
Placebo Comparator: A4 Vitamin D3 2400 IU
Orally for one year
Drug: vitamin D3
Oral, one capsule daily of vitamin D3 (400IU, 800IU, 1600 IU, or 2400IU) plus calcium citrate (1-4 tablets) twice daily to reach a total calcium intake of 1200-1400 mg/day
Other Name: Calcium citrate (Citracal)
Placebo Comparator: Placebo
Placebo for one year

Detailed Description:

Vitamin D is a unique nutrient in that its requirement can be met by both endogenous production from sun and from diet, which makes it difficult to determine the actual requirements as for other nutrients. The current recommended dietary reference intake (DRI) for vitamin D is 200 IU for adults between 25- 50 years, 400 IU for adults between 51-70 years and 600 IU for adults 70 years of age. In view of many scientists in the field of vitamin D, the current DRI of vitamin D is too low. This is mainly because of the increase in prevalence of vitamin D deficiency observed in the population based on measured serum 25OHD levels. It is now recognized that serum 25OHD is an indicator of vitamin D status. There is a growing consensus that serum 25OHD concentration of at least 30-32 ng/ml are needed to reduce serum Parathyroid hormone (PTH) and reduce bone loss. Also, research over the last two decades has provided additional evidence that higher vitamin D levels (25OHD 30ng/ml) are necessary for optimum overall health and prevent disease. There is no clear view of the amount of vitamin D intake required to maintain the optimum level of serum 25OHD levels in the population of all ages and there are no systematic dose response studies of vitamin D in women of all ages. A few studies carried out with different sexes and age groups have suggested that an untreated subject with a serum 25OHD concentration of 20 ng/ml would need a daily dose of ~1700 IU/d of Vitamin D3 to reach a serum 25OHD of 32 ng/ml in Caucasians, while in African Americans the Vitamin D3 requirement would be higher - 1860-2480 IU/d.

The current proposal aims at studying the dose response effect of vitamin D3 400 IU, 800 IU,1600 IU and 2400 IU or placebo on serum 25OHD and serum PTH in young women with vitamin D insufficiency (serum 25OHD <20 ng/ml) and an adequate calcium intake of 1000mg/day.

Another aim of the study is to establish the minimum effective dose of vitamin D3 which Normalizes PTH in Caucasian and African American young women. Vitamin D dose that reduces serum PTH to normal level in 97% of normal population is the recommended dietary allowance.

We will also establish the safety of these higher doses of vitamin D supplementation relating to hypercalcemia/hypercalcuria.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Premenopausal women, minimum age 25 years, maximum age 45 years. (Women with hysterectomy and/or oophorectomy must have a premenopausal FSH level.)
  2. Serum 25OHD level: 5 - 20 ng/ml
  3. BMI < 45 kg/m2.
  4. Willing to discontinue vitamin D supplements after entering the study.
  5. Negative pregnancy test before BMD and calcium absorption tests.
  6. Willing to give signed informed consent form
  7. Subject is Caucasian or African American

Exclusion Criteria:

  1. Cancer (exceptions: basal cell carcinoma or if cancer occurred more than 10 years ago) or terminal illness.
  2. Previous hip fracture.
  3. Hemiplegia.
  4. Uncontrolled type I diabetes ± significant proteinuria or fasting blood sugar >140 mg in type II diabetes.
  5. Kidney stones- > 2 in a lifetime.
  6. Chronic renal failure (serum creatinine >1.4 mg/dl).
  7. Evidence of chronic liver disease, including alcoholism.
  8. Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity.
  9. Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide) or Fluoride in the last 6 months.
  10. Previous treatment within the last 6 months with calcitonin or estrogen (except birth control pills).
  11. Chronic high dose corticosteroid therapy (> 10 mg/day) for over 6 months and not within the last 6 months.
  12. Anticonvulsant therapy. (Dilantin, Phenobarbital)
  13. High dose thiazide therapy (> 37.5 mg).
  14. 24 hour urine calcium > 290 mg on 2 baseline tests.
  15. Serum calcium exceeding upper normal limit on 2 baseline tests.
  16. BMD. T-score less than -3.0 for spine or hip.
  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: NCT00662844

Sponsors and Collaborators
Creighton University
University of Nebraska
Investigators
Principal Investigator: J C Gallagher, MD Creighton University Medical Center
  More Information

Publications:
Responsible Party: J.C. Gallagher, Professor of Medicine, Creighton University
ClinicalTrials.gov Identifier: NCT00662844     History of Changes
Other Study ID Numbers: PR065013, DOD. CDMRP. W81XWH-07-1-0201
Study First Received: April 17, 2008
Last Updated: March 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Creighton University:
Vitamin D insufficiency,vitamin D3 treatment,young women

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

ClinicalTrials.gov processed this record on October 23, 2014