Inter-relationship Between Vitamin D Requirements and Calcium Intake in Older Adults

NCT01990872 | Completed DMC

• 1 other identifier: PR-IC-1111-10005
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This winter-based placebo-controlled, single-dose vitamin D randomized controlled trial (RCT) aims to examine the impact of various levels of habitual calcium intake on dietary vitamin D requirements in older adults stratified by calcium intake. This will provide new data on the impact of different levels of calcium intake, ranging from low/moderate to high, on winter serum 25(OH)D levels, and their utilization and catabolism in adults.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D status; 25-hydroxyvitamin D; Vitamin D3; RCT; Calcium intake; Dietary requirement

Outcome Measures

Primary Outcomes (1)

• Response of serum 25(OH)D concentration over winter in subjects stratified by calcium intake

  0, 8, 15 weeks

Secondary Outcomes (6)

• Serum albumin-adjusted calcium

  0, 8, 15 weeks

• serum parathyroid hormone

  0, 8, 15 weeks

• Serum 24,25(OH)2D

  0 and 15 weeks

• Serum 1,25(OH)2D

  0 and 15 weeks

• Serum free 25(OH)D

  0 and 15 weeks

Study Arms (4)

Placebo in high calcium group

PLACEBO COMPARATOR

Placebo + habitual dietary calcium intake (\>1000 mg/d)

Dietary Supplement: Placebo

Vitamin D3 in low/moderate calcium group

ACTIVE COMPARATOR

Vitamin D3 (20 microgram/day) + habitual calcium intake \<700 mg/d

Dietary Supplement: Vitamin D3 (20 micrograms/day)

Placebo in low/moderate calcium group

PLACEBO COMPARATOR

Placebo + habitual calcium intake \<700 mg/d

Dietary Supplement: Placebo

Vitamin D3 in high calcium group

ACTIVE COMPARATOR

Vitamin D3 (20 microgram/day) + habitual calcium intake (\>1000 mg/d)

Dietary Supplement: Vitamin D3 (20 micrograms/day)

Interventions

Vitamin D3 (20 micrograms/day) DIETARY_SUPPLEMENT

Vitamin D3 (20 micrograms/day)

Vitamin D3 in high calcium group; Vitamin D3 in low/moderate calcium group

Placebo DIETARY_SUPPLEMENT

Placebo (0 micrograms vitamin D3/day)

Placebo in high calcium group; Placebo in low/moderate calcium group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting white men and women aged ≥ 50 y

You may not qualify if:

• Unwilling to discontinue consumption of vitamin D-containing supplements 4 wks before the initiation of the study and throughout the study.
• Planning to take a winter vacation (during the course of the 15-wk intervention) to a location at which either the altitude or the latitude was predicted to result in significant cutaneous vitamin D synthesis from solar radiation (e.g., a winter sun coastal resort or a mountain ski resort)
• Use of tanning facilities of any type.
• Pregnancy or planning to become pregnant during the study
• A severe medical illness,
• hypercalcaemia,
• Known intestinal malabsorption syndrome,
• Excessive alcohol use,
• Taking medications known to interfere with vitamin D metabolism

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork, Cork, Ireland

Cork, Ireland

Location

Related Publications (2)

• Cashman KD, Kinsella M, Walton J, Flynn A, Hayes A, Lucey AJ, Seamans KM, Kiely M. The 3 epimer of 25-hydroxycholecalciferol is present in the circulation of the majority of adults in a nationally representative sample and has endogenous origins. J Nutr. 2014 Jul;144(7):1050-7. doi: 10.3945/jn.114.192419. Epub 2014 May 14.

  PMID: 24828024 DERIVED

• Cashman KD, Hayes A, O'Donovan SM, Zhang JY, Kinsella M, Galvin K, Kiely M, Seamans KM. Dietary calcium does not interact with vitamin D(3) in terms of determining the response and catabolism of serum 25-hydroxyvitamin D during winter in older adults. Am J Clin Nutr. 2014 Jun;99(6):1414-23. doi: 10.3945/ajcn.113.080358. Epub 2014 Apr 2.

  PMID: 24695896 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Kevin D Cashman, BSc. PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Food and Health

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

IE (1)