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Optimizing Vitamin D in the Elderly

Optimizing Vitamin D in the Elderly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01554241
Enrollment
86
Registered
2012-03-14
Start date
2012-09-30
Completion date
2014-09-30
Last updated
2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deficiency of Vitamin D3

Keywords

vitamin D3, D3, cholecalciferol, 25-OH vitamin D, elderly, nursing home resident

Brief summary

Vitamin D deficiency is highly prevalent in older people in the absence of vitamin D supplementation. The limited data available show marked inter-individual variability in response to vitamin D supplementation in very old, frail elderly with almost 25% remaining vitamin D deficient (25-OH D \< 20 ng/mL) when receiving the currently recommended 800 IU/day vitamin D. This proposal is for exploratory research on the use of a wide range of oral vitamin D3 doses in frail elderly living in controlled living environments.

Detailed description

The investigators will determine the dose response relationship of circulating total and unbound 25-OH vitamin D3 to supplemental vitamin D3 at daily doses of 800 (currently recommended for the elderly), 2000, and 4000 IU or 50,000 IU/weekly in a randomized blinded investigation of 16 weeks duration. The investigators will also compare the efficacy of each dosing regimen in achieving 25-OH vitamin D levels \>20 ng/mL (50 nmol/L) and identify covariates that contribute to inter-individual variation in the dose response relationship. In patients with osteoporosis, relationships between unbound vs. total 25-OH on intact parathyroid hormone and a marker of bone resorption (beta-Ctx) will be analyzed. The investigators will also examine responses of inflammatory cytokines. Note: as of April 8,2014, there will be no further enrollment in the 50,000 IU/weekly dose group

Interventions

DIETARY_SUPPLEMENTD3 2000 IU/day

2000 IU/day D3

DIETARY_SUPPLEMENTD3 4000 IU/day

vitamin D3 4000 IU/day

DIETARY_SUPPLEMENTD3 50,000 IU weekly

vitamin D3 50,000 IU/week

DIETARY_SUPPLEMENTvitamin D3 800 IU/day

vitamin D3 800 IU/day

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age over 65 * medically stable * residing in long-term care or assisted living

Exclusion criteria

* hypercalcemia or high risk for hypercalcemia * active cancer or malignancy other than non-melanoma skin cancer * severe renal disease (eGFR \<30 ml/mkin/M2) * small bowel resection or intestinal bypass surgery * hyperparathyroidism * granulomatous disease * clinically unstable (changes in medications or diagnoses within a month, hospitalizations, within 6 months) * allergy to vitamin D

Design outcomes

Primary

MeasureTime frameDescription
Total 25-OH Vitamin D3 Level16 weekscirculating total 25-OH vitamin D concentration

Secondary

MeasureTime frameDescription
Free 25-OH Vitamin D316 weekscirculating free 25-OH vitamin D3 concentration

Countries

United States

Participant flow

Pre-assignment details

Following participant consent/enrollment, 4 were ineligible due to clinical instability or abnormal laboratory tests and one withdrew consent.

Participants by arm

ArmCount
Vitamin D3 800 IU/Day
recommended daily dosage of 800 IU/day D3 vitamin D3 800 IU/day: vitamin D3 800 IU/day
23
2000 IU/Day D3
D3 2000 IU/day D3 2000 IU/day: 2000 IU/day D3
20
Vitamin D3 4000 IU/Day
D3 4000 IU/day D3 4000 IU/day: vitamin D3 4000 IU/day
24
50,000 IU/Week D3
D3 50,000 IU weekly D3 50,000 IU weekly: vitamin D3 50,000 IU/week
14
Total81

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDeath3110
Overall Studyprotocol specified change in eGFR0010
Overall Studyprotocol specified renal stone0001
Overall StudyWithdrawal by Subject0020

Baseline characteristics

Characteristic2000 IU/Day D3Vitamin D3 4000 IU/DayVitamin D3 800 IU/Day50,000 IU/Week D3Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
20 Participants24 Participants23 Participants14 Participants81 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Continuous85.9 years
STANDARD_DEVIATION 8.5
89.5 years
STANDARD_DEVIATION 6.6
84.9 years
STANDARD_DEVIATION 8.7
90.1 years
STANDARD_DEVIATION 6.6
87.4 years
STANDARD_DEVIATION 7.9
Region of Enrollment
United States
20 participants24 participants23 participants14 participants81 participants
Sex: Female, Male
Female
13 Participants16 Participants13 Participants10 Participants52 Participants
Sex: Female, Male
Male
7 Participants8 Participants10 Participants4 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
1 / 231 / 200 / 240 / 14
serious
Total, serious adverse events
7 / 232 / 201 / 243 / 14

Outcome results

Primary

Total 25-OH Vitamin D3 Level

circulating total 25-OH vitamin D concentration

Time frame: 16 weeks

ArmMeasureValue (MEAN)Dispersion
Vitamin D3 800 IU/DayTotal 25-OH Vitamin D3 Level33 ng/mLStandard Deviation 6
2000 IU/Day D3Total 25-OH Vitamin D3 Level34 ng/mLStandard Deviation 6
Vitamin D3 4000 IU/DayTotal 25-OH Vitamin D3 Level43 ng/mLStandard Deviation 10
50,000 IU/Week D3Total 25-OH Vitamin D3 Level61 ng/mLStandard Deviation 14
Comparison: Comparisons of concentrations in D3 dosing groups at study end were made by ANOVA. Adherence of 80% was pre-specified for inclusion in analyses. .p-value: <0.0001ANOVA
p-value: =0.56ANOVA
p-value: <0.0009ANOVA
p-value: <0.0001ANOVA
p-value: <0.006ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary

Free 25-OH Vitamin D3

circulating free 25-OH vitamin D3 concentration

Time frame: 16 weeks

ArmMeasureValue (MEAN)Dispersion
Vitamin D3 800 IU/DayFree 25-OH Vitamin D38.7 pg/mLStandard Deviation 2.1
2000 IU/Day D3Free 25-OH Vitamin D39.5 pg/mLStandard Deviation 1.7
Vitamin D3 4000 IU/DayFree 25-OH Vitamin D312.2 pg/mLStandard Deviation 4.3
50,000 IU/Week D3Free 25-OH Vitamin D316.8 pg/mLStandard Deviation 4.3
p-value: <0.0001ANOVA
p-value: =0.47ANOVA
p-value: <0.002ANOVA
p-value: <0.0001ANOVA
p-value: <0.02ANOVA
p-value: <0.0001ANOVA
p-value: <0.0003ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026