Family Member Clinical Trial
Official title:
The Effect of Vitamin D on Serum Vitamin D Levels, Bone Formation, Resorption, and Mineral Density, Inflammation, Flexibility, and Balance in the Elderly
The purpose of this study is to compare vitamin D deficient and vitamin D sufficient elderly individuals and examine the effect of a vitamin D dietary supplement on serum vitamin D level, bone formation, resorption, and mineral density, flexibility, balance, general inflammation,and quality of life. Enhancing nutritional status is necessary to prevent the continued proliferation of chronic diseases, e.g., bone disease and other chronic disorders thought to now be related to low levels of vitamin D, which are some of the leading disablers and killers of Americans. Americans also have difficulties with compliance to prescription medications due to their toxicity and side effects. This study aims to learn more about how a vitamin D nutritional supplement may improve nutritional status and enable the body to normalize system functioning,which may improve the quality of life for people with vitamin D deficiency. The results of this research will be used to determine if vitamin D is beneficial for overall health among elderly individuals.
The proposed study has two parts and is observational (first part) and experimental (second
part) in design. The purpose of the first part of this study is a cross-sectional
investigation of the relationship among vitamin D status, vitamin D intake and sun exposure,
and physical performance in 130 community dwelling older adult (≥55 years old). The purpose
of the second part of the study is a 6-month, randomized, double-blind, placebo-controlled
trial to evaluate the effect of vitamin D supplementation (Bio-D-Mulsion Forte®) for
improving physical performance, serum levels of 25-OH-vitamin D, PTH, bone formation
(osteocalcin), bone resorption (type 1 cross linked C telopeptide (CTX)), and bone mineral
density (dual energy x-ray absorptiometry in a sub-sample of 20 participants) in 40
participants (≥55 years of age) who are vitamin D insufficiency at baseline (<30 ng/ml serum
25(OH)D). Secondary outcomes will include body composition, lower back/hamstring
flexibility, balance, gustatory response to the treatment, general inflammation, quality of
life, depression, fear of falling, history of falls, and food security. Information on sun
exposure, vitamin D and calcium intake, physical activity level, and reflectance calorimetry
will also be collected. Participants will be assessed at baseline and 6-months follow-up.
This part of the study will consist of two treatment arms: (a) vitamin D dietary nutritional
supplement and (b) placebo.
The primary risk for the placebo group is that they will show no improvement in serum levels
of 25-OH-vitamin D, bone formation, bone resorption, bone mineral density, and secondary
outcomes associated with vitamin D supplementation. However, they are not being restricted
in any way to receive vitamin D through sunlight exposure and their food. Each participant
in the placebo group will also receive a 6-month supply of the vitamin D supplement
(Bio-D-Mulsion Forte®) at the conclusion of their participation in the study. Additionally,
the risk of placebo is also offset by the knowledge gained from actually receiving a serum
level 25-OH-vitamin D score at baseline and 6-months follow-up, which is not typically
assessed by the average provider. Finally, the short-term period of the study does not
increase long-term health risks associated with the study, as other studies have utilized
placebo-controlled trials with vitamin D deficient adults previously and have observed no
adverse effects . Normal serum levels of 25-OH-vitamin D can be achieved within 2-5 months
according to the literature.
The health risks associated with consuming a vitamin D dietary supplement are inconclusive.
Hypercalcemia is one potential adverse effect, but according to one review no increases in
mean calcium levels occurred with higher vitamin D intakes tested in controlled trials up to
100,000 IU per day. For single cases of hypercalcemia from randomized controlled trials,
cases of mild hypercalcemia were reported in 2 of 28 studies, which resolved on repeating
fasting samples in one study and were actually more frequent in the placebo group in the
other study. Additionally, hypercalcemia has been mostly found in cases of persons with
serum levels of 25(OH)D greater than 240 nmol/L.
An increased risk of nephrolithiasis was found in one randomized controlled trial (the
Women's Health Initiative (WHI)), which tested 400 IU vitamin D in combination with 1000 mg
of calcium. The reason for nephrolithiasis in this study is unclear; factors include: (1)
this study may have been large enough to detect a small risk of nephrolithiasis with vitamin
D supplementation; (2) nephrolithiasis was caused by the calcium supplement intake taken in
combination with the vitamin D as part of the protocol; and/or (3) the nephrolithiasis was
caused by the additional calcium and vitamin D supplements taken by the majority of
participants outside the study protocol. The low dose of vitamin D used in the WHI argues
against a causal role of the increased risk of nephrolithiasis. Based on epidemiologic data,
a higher vitamin D intake was not independently associated with nephrolithiasis in one large
cohort consistent with findings from a recent study of 18 healthy postmenopausal women with
vitamin D deficiency where vitamin D supplementation did not increase urinary calcium
excretion. On the other hand, calcium supplementation was associated with a 20% increased
risk of nephrolithiasis in the Nurses Health Study I.
The issue of vascular calcification has also been noted as a potential risk of vitamin D
supplementation. However, reports in the literature continue to be restricted to extremely
high doses of vitamin D3 or administration of the active hormonal form, 1,25(OH)2D3 and/or
related analogues, and most of these reports are in animals, not humans. No credible
evidence exists to support the notion that oral vitamin D doses up to and even exceeding
10,000 IU per day are associated with vascular calcification in humans, including dialysis
patients, and no basis exists for identifying vascular calcification as a critical effect.
Participants may experience discomfort while answering the questionnaires and while
undergoing the venipuncture, but they may stop the assessments at any time. Although all
measures to protect confidentiality will be put in place, the possibility exists that
electronic data could be jeopardized. In the remote case that such event occurs, it will be
immediately reported to the IRB.
The vitamin D dietary supplement should be harmless without any food allergy or sensitivity.
No episodes of side effects have been reported to Biotics Research Corporation, the
manufacturer, by consumers in the previous 5 years.
A toxicology search for each component reveals no unique toxicity characteristic of the
materials. As reported by Biotics Research Corporation, thousands of people currently use
Bio-D-Mulsion Forte®, and Biotics Research Corporation is unaware of significant toxicities.
A major concern with raw natural products is the presence of contaminants.
Biotics Research Corporation operates in accordance with D-SHEA regulations, and
Bio-D-Mulsion Forte® is made of the highest purity, quality, and potency. Biotics Research
Corporation manufacturers their products under strict GMP guidelines in an FDA-registered
facility, is licensed by the Texas Department of State Health Services Regulatory Licensing
Unit as a Food and Non-prescription Drug Manufacturer, and is licensed by Health Canada
(Site License) and is considered to be in compliance with the GMP requirements of their
Natural Health Products Regulations. Biotics Research Corporation conducts multiple quality
control tests on all of its products.
Participants will incur no additional appreciable psychological or social risks by
participating in this study, although they may undergo psychological and physical discomfort
sometimes. The process of interviewing during the assessment may cause discomfort.
Discomfort or fatigue may also be experienced in completing the assessment battery.
Alternatives to this study include prescription medications, sun exposure, exercise, dietary
modification, and other nutritional supplements. The risks of medications can be very
significant, including life-threatening, but the risk of taking nutritional supplements is
not totally understood, since they are not regulated by the FDA. Medications and nutritional
supplements, as part of a change in lifestyle behaviors, may also prove to be beneficial for
improving serum vitamin D levels, but their long-term use has unknown consequences.
The information obtained in this study will help in determining the efficacy of using a
dietary supplement for improving serum vitamin D levels. By participating in the study,
subjects may experience improved serum vitamin D level, bone formation, bone resorption,
bone mineral density according to DEXA scan, flexibility, balance, and quality of life,
while reducing their risk for other diseases. The risk of participating in this study is
reasonable because the improvements in serum vitamin D level, bone formation, bone
resorption, bone mineral density, flexibility, balance, gustatory response to the treatment,
general inflammation, and quality of life associated with improved nutritional status will
be enhanced.
The investigators are looking at an older population due to changes in all of our outcomes
that are typically associated with aging. No consensus exists on what age is considered
elderly, but the investigators have chosen 55 to have a wider age range. Other investigators
have used non-elderly participants with a similar or higher dose of vitamin D
supplementation.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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