NCT00472823

Brief Summary

The purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

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

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

4.3 years

First QC Date

May 10, 2007

Last Update Submit

March 11, 2016

Conditions

OsteoporosisAging

Keywords

cholecalciferolvitamin D deficiencybone densitydietary calciumhypercalcemiahypercalciuria

Outcome Measures

Primary Outcomes (1)

  • Changes in Serum 25-hydroxyvitamin D (25OHD) and parathyroid hormone (PTH) levels

    Baseline, 6months,12 months

Secondary Outcomes (15)

  • Calcium absorption

    Baseline and 12 months

  • Serum/urine calcium

    Baseline and every 3 months

  • Bone markers

    Baseline, and 12 months

  • Bone density

    Baseline and 12 months

  • Muscle strength

    Baseline,6 months,12 months

  • +10 more secondary outcomes

Study Arms (8)

vitamin D3 400 IU daily

EXPERIMENTAL

vitamin D3 400 IU daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium Citrate (Citracal)

vitamin D3 800 IU daily

EXPERIMENTAL

vitamin D3 800 IU daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium Citrate (Citracal)

vitamin D3 1600 IU daily

EXPERIMENTAL

vitamin D3 1600 IU daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium Citrate (Citracal)

vitamin D3 2400 IU daily

EXPERIMENTAL

vitamin D3 2400 IU daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium Citrate (Citracal)

vitamin D3 3200 IU daily

EXPERIMENTAL

vitamin D3 3200 IU daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium Citrate (Citracal)

vitamin D3 4000 IU daily

EXPERIMENTAL

vitamin D3 4000 IU daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium Citrate (Citracal)

vitamin D3 4800 IU daily

EXPERIMENTAL

vitamin D3 4800 IU daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium Citrate (Citracal)

placebo

PLACEBO COMPARATOR

matched to vitamin D tablet

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Orally for one year

placebovitamin D3 1600 IU dailyvitamin D3 2400 IU dailyvitamin D3 3200 IU dailyvitamin D3 400 IU dailyvitamin D3 4000 IU dailyvitamin D3 4800 IU dailyvitamin D3 800 IU daily
Calcium Citrate (Citracal)DIETARY_SUPPLEMENT

Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily

Also known as: Citracal
vitamin D3 1600 IU dailyvitamin D3 2400 IU dailyvitamin D3 3200 IU dailyvitamin D3 400 IU dailyvitamin D3 4000 IU dailyvitamin D3 4800 IU dailyvitamin D3 800 IU daily

Eligibility Criteria

Age57 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 7 years post-menopause
  • Serum 25OHD level 5 ng/ml to 20 ng/ml
  • BMI less than or equal to 40 kg/m2
  • Willing to discontinue multivitamins that contain vitamin D during the study

You may not qualify if:

  • Cancer (except basal cell carcinoma) or terminal illness
  • Previous hip fracture
  • Hemiplegia (paralysis of one side of the body)
  • Uncontrolled type I diabetes or fasting blood sugar greater than 140 mg in type II
  • Kidney stones more than twice in a lifetime
  • Chronic renal failure
  • Evidence of chronic liver disease, including alcoholism
  • Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity
  • Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide or Fluoride) in the last 6 months
  • Previous treatment within the last 6 months with calcitonin or estrogen
  • Chronic high dose corticosteroid therapy (more than 10 mg per day) for over 6 months and not within the last 6 months
  • Anticonvulsant therapy
  • High dose thiazide therapy (more than 37.5 mg)
  • hour urine calcium greater than 290 mg on 2 baseline tests
  • Serum calcium exceeding upper normal limit on 2 baseline tests
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (9)

  • Gallagher JC, Kinyamu HK, Fowler SE, Dawson-Hughes B, Dalsky GP, Sherman SS. Calciotropic hormones and bone markers in the elderly. J Bone Miner Res. 1998 Mar;13(3):475-82. doi: 10.1359/jbmr.1998.13.3.475.

    PMID: 9525348BACKGROUND

  • Holick MF, Siris ES, Binkley N, Beard MK, Khan A, Katzer JT, Petruschke RA, Chen E, de Papp AE. Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab. 2005 Jun;90(6):3215-24. doi: 10.1210/jc.2004-2364. Epub 2005 Mar 29.

    PMID: 15797954BACKGROUND

  • Aloia JF, Talwar SA, Pollack S, Feuerman M, Yeh JK. Optimal vitamin D status and serum parathyroid hormone concentrations in African American women. Am J Clin Nutr. 2006 Sep;84(3):602-9. doi: 10.1093/ajcn/84.3.602.

    PMID: 16960175BACKGROUND

  • Smith LM, Gallagher JC. Effect of vitamin D supplementation on total and free 25 hydroxyvitamin D and parathyroid hormone. An analysis of two randomized controlled trials. J Intern Med. 2019 Dec;286(6):651-659. doi: 10.1111/joim.12950. Epub 2019 Jul 29.

    PMID: 31215092DERIVED

  • Smith LM, Gallagher JC, Kaufmann M, Jones G. Effect of increasing doses of vitamin D on bone mineral density and serum N-terminal telopeptide in elderly women: a randomized controlled trial. J Intern Med. 2018 Dec;284(6):685-693. doi: 10.1111/joim.12825. Epub 2018 Sep 17.

    PMID: 30137647DERIVED

  • Gallagher JC, Smith LM, Yalamanchili V. Incidence of hypercalciuria and hypercalcemia during vitamin D and calcium supplementation in older women. Menopause. 2014 Nov;21(11):1173-80. doi: 10.1097/GME.0000000000000270.

    PMID: 24937025DERIVED

  • Gallagher JC, Jindal PS, Smith LM. Vitamin D does not increase calcium absorption in young women: a randomized clinical trial. J Bone Miner Res. 2014;29(5):1081-7. doi: 10.1002/jbmr.2121.

    PMID: 24166866DERIVED

  • Gallagher JC, Peacock M, Yalamanchili V, Smith LM. Effects of vitamin D supplementation in older African American women. J Clin Endocrinol Metab. 2013 Mar;98(3):1137-46. doi: 10.1210/jc.2012-3106. Epub 2013 Feb 5.

    PMID: 23386641DERIVED

  • Gallagher JC, Sai A, Templin T 2nd, Smith L. Dose response to vitamin D supplementation in postmenopausal women: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):425-37. doi: 10.7326/0003-4819-156-6-201203200-00005.

    PMID: 22431675DERIVED

MeSH Terms

Conditions

OsteoporosisVitamin D DeficiencyHypercalcemiaHypercalciuria

Interventions

CholecalciferolCalcium Citrate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersCalcium Metabolism DisordersWater-Electrolyte ImbalanceUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsCalcium CompoundsInorganic ChemicalsCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • J C Gallagher, MD

    Creighton University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 14, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)