How Much Vitamin D is Required to be Protective Against Deficiency During the Winter Months?

NCT01437696 | Completed Phase 4

• 1 other identifier: HW-11-02
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the skin (between April and October) or by a few foods such as fatty fish, eggs or fortified milk and margarine. This study has 3 main goals which are to determine if Veteran's have enough vitamin D stored in their body, if adding a supplement of 2000 IU/d is enough to correct low vitamin D stores and, if specially formulated foods using an approved vitamin D supplement, are appropriate to maintain vitamin D stores in relation with functional and cognitive status. Initially, a 2000 IU supplement of vitamin D will be provided for 8 weeks. After this period, the participants will be randomly separated into 3 groups (Group A, B or C) for a period of 24 weeks. Group A will receive their usual menu. Group B will receive their usual menu with 1 portion of food containing 500 IU of added vitamin D. Group C will receive their usual menu with 1 portion of food containing 1000 IU of added vitamin D. Food intake will be assessed every 8 weeks and blood samples will be taken every 4 weeks to monitor change in blood concentration of vitamin D and other indicators of bone health. The investigators will document weight and height, hand grip strength, the mid-arm and mid-calf circumferences, the capacity to perform activities of daily living, the number of prescriptions and changes in health condition. The investigators will also take an X-ray the tibia and upper arm to document the amount and quality of bones in those regions. A total of 60 veterans of Ste-Anne's Hospital will participate in this study. Knowing more about vitamin D status and intake will help in confirming the required vitamin D recommendations for the elderly men living in long-term care institutions.

Conditions

Vitamin D Deficiency

Keywords

Aging; Vitamin D; Bone health; Inflammation; Men

Outcome Measures

Primary Outcomes (2)

• Change in 25(OH)D plasma concentrations

  Fasted morning blood samples will be taken monthly for assessment of 25(OH)D plasma concentrations.

  Baseline and following 8 weeks of the observation phase. Also following 1, 2, 3, 4, 5 and 6 months of the active supplementation phase.

• Changes in Vitamin D intake from foods and supplements

  Using food records, vitamin intake will be assessed for 3 days. The records will be collected by a registered dietitian.

  Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.

Secondary Outcomes (6)

• Change in bone mineral density

  Baseline and following 6 months of the active supplementation phase (32 week timepoint).

• Changes in functional mobility

  Baseline and following 32 weeks of study involvement

• Change in chronic pain over time

  Baseline and following 8 weeks of the observation phase. Also following 6 months of the active supplementation phase (32 week timepoint).

• Changes in biochemistry measurements during the study period

  Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.

• Changes in inflammatory markers and bone metabolism markers

  Baseline and following 8 weeks of the observation phase. Also following 2, 4 and 6 months of the active supplementation phase.

Study Arms (3)

Vitamin D fortified food 500 IU

EXPERIMENTAL

One portion of a specific food item will be provided each day. 500 IU Vitamin D added.

Dietary Supplement: Vitamin D

Vitamin D fortified food 1000 IU

EXPERIMENTAL

One portion of a specific food item will be provided each day. 1000 IU Vitamin D added.

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

One portion of a specific food item will be provided each day. No vitamin D added.

Other: placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

A liquid cholecalciferol at a dosage of 500IU will be added to a specific food and provided to the participants once a day for 24 weeks.

Vitamin D fortified food 500 IU

placebo OTHER

No liquid cholecalciferol will be added to the food.

Placebo

Eligibility Criteria

• Age: 70 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• Individuals with chronic diseases will be permitted to participate as long as the disease is not end-stage (ie prognosis of more than 4 months).
• Not excluding co-morbidities or poor cognition is consistent with the work of others in the area.
• Lastly combined oral and enteral feeding modes will be included since the majority quickly transition to foods but some do take a meal-replacement/liquid supplement.
• End-stage renal disease due to altered vitamin D metabolism and use of vitamin D analogues
• End-stage liver disease
• Untreated hyperparathyroid conditions such as cancer and metabolic bone disease except for osteoporosis and osteomalacia
• Any condition that requires enteral feeding alone as feeding route will be excluded since this oral intake, even if only partial, is a critical measurement.

Sponsors & Collaborators

• McGill University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Ste. Anne's Hospital

Ste. Anne-de-Bellevue, Quebec, H9X1Y9, Canada

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Inflammation; Multiple Endocrine Neoplasia Type 1

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hope A Weiler, PhD, RD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 21, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

CA (1)