NCT02969850

Brief Summary

Although the African-American (AA) population tends to have lower serum 25(OH)D levels compared to whites, there is no evidence that the lower 25(OH)D levels in African-Americans are harmful. In fact, skeletal health is superior in AA. It is clear that total serum 25(OH)D concentrations do not reflect the same risk/benefit ratio in AA compared to white women and is, therefore, an inappropriate biomarker in this population. The investigators wish to investigate whether free 25(OD)D and Vitamin D Metabolite Ratio (VMR, ratio of 25(OH)D to 24,25(OH)2D) are preferable biomarkers to total 25(OH)D. The investigators propose a six month randomized double blinded study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
444

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

November 10, 2016

Last Update Submit

October 20, 2021

Conditions

New Biomarkers for Measuring Vitamin D Level

Keywords

vitamin D supplementationcalcium supplementation

Outcome Measures

Primary Outcomes (2)

  • Compare free 25(OH)D levels in Caucasian women (current study) and AA women (from prior study)

    VDBP will be measured and free 25(OH)D calculated

    baseline

  • Compare Vitamin D metabolite ratio (VMR) in Caucasian women (current study) and AA women (from prior study)

    serum 24,25(OH)2D and serum 25(OH)D will be measured and VMR calculated

    baseline

Secondary Outcomes (3)

  • Relationship between free 25(OH)D and two measures of bone health (PTH and BMD)

    baseline

  • Relationship between VMR and two measures of bone health (PTH and BMD)

    baseline

  • Relationship between vitamin D intake and Change in Physical Performance Assessment (SPPB)

    baseline and 6 months

Study Arms (2)

Vitamin D Supplementation

EXPERIMENTAL

Participant will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level. If subject has insufficient dietary calcium intake, calcium supplementation will be provided in the form of one 600mg CaCO3 pill to achieve a total calcium intake of 1200mg/day.

Dietary Supplement: Vitamin D SupplementationDietary Supplement: Calcium

Placebo

PLACEBO COMPARATOR

Participant will receive a placebo. If subject has insufficient dietary calcium intake, calcium supplementation will be provided in the form of one 600mg CaCO3 pill to achieve a total calcium intake of 1200mg/day.

Other: PlaceboDietary Supplement: Calcium

Interventions

Vitamin D SupplementationDIETARY_SUPPLEMENT

Subjects in this group will receive initial dose of 2400, 3600, or 4800 IU of vitamin D3, based on her serum vitamin D level. Dose will be adjusted at 3 month visit to maintain serum vitamin D level at a desirable level.

Vitamin D Supplementation
PlaceboOTHER

Subjects in this group will receive a placebo.

Placebo
CalciumDIETARY_SUPPLEMENT

If dietary calcium intake is insufficient in participants of either group, they will be given a calcium supplement in the form of one 600mg pill of CaCO3 to bring them up to an intake of 1200mg/day.

PlaceboVitamin D Supplementation

Eligibility Criteria

Age60 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory women older than 60 years of age. Women who are ambulatory with an assistive device such as cane or walker may be included. LMP must be \> 5 years ago.
  • Self declared as white.
  • nmol/L \< Serum 25(OH)D level \< 65 nmol/L.
  • Willingness to take study drug and participate for 6 months in the trial.
  • Willingness to refrain from the use of self-administered Vitamin D and Calcium supplements during the trial.

You may not qualify if:

  • Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.
  • BMD total hip below -2.5 standard deviation (using NHANES III adult young white men and women as the point of reference) or history of osteoporotic fracture.
  • Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment on DXA.
  • Treatment with HRT, SERMs, calcitonin, PTH, strontium ranelate, androgens, bisphosphonates, Denosumab or anabolic steroids during 6 months prior to entry.
  • Use of systemic corticosteroids (oral or IV) within the last year at an average dose of greater than 5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.
  • Mini-Mental State Exam score below 21
  • Hypercalcemia (serum calcium \> 10.6 mg/dl) or history of primary hyperparathyroidism.
  • History of hypercalciuria, kidney stones, or 24hr urine calcium \>261 mg/day on screening.
  • Use of medications that influence bone metabolism (e.g. anticonvulsants).
  • Significant deviation from normal in either: history, physical examination or laboratory tests as evaluated by the Principle Investigator. Participants with a history of uncontrolled hypertension, uncontrolled diabetes, hypercalciuria, nephrolithiasis and active sarcoidosis or tuberculosis will also be excluded.
  • Participation in another investigational trial 30 days prior to screening.
  • Spinal disease that affects interpretation of bone densitometry like scoliosis with a Cobb angle greater than 15o, history of surgery at lumbosacral spine.
  • Bilateral hip replacement.
  • Currently smoking more than 10 cigarettes daily.
  • Currently consuming more than 2 units of alcohol daily. (One unit is equivalent to a standard glass of beer (285ml), a single measure of spirits (30ml), a medium-sized glass of wine (120ml), or 1 measure of an aperitif (60ml)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Interventions

Calcium

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • John Aloia, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

  • Mageda Mikhail, MD

    Winthrop University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 21, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)