Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 8 - 14 |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | October 2011 |
The study objective is to characterize the threshold levels of serum 25-hydroxyvitamin D for
the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian
children.
We propose a 6 month randomized placebo controlled trial of vitamin D (vitamin D3 1000
IU/day vs. placebo) initiated during October through March (during fall and winter) in 8 to
14 year old African American and Caucasian children. The results of the trial will help
establish the cutoff threshold value of serum 25(OH)D for defining vitamin D insufficiency
in preadolescent and adolescent children. Safety of vitamin D supplementation will be
assessed by measuring serum calcium at 0, 2 and 6 months and by monitoring for adverse
events. Currently recommended adequate intake for vitamin D of 200 IU daily may not meet the
body's daily needs for vitamin D. Therefore, it is likely that a higher level of daily
vitamin D intake may be needed to meet the body's skeletal and non-skeletal demands for
vitamin D. Determining the dietary required intake of vitamin D for the prevention of
vitamin D insufficiency during childhood has immense public health potential for addressing
health disparities and ensuring better bone health during adulthood. The primary outcome
measure will be serum 25(OH)D and parathyroid hormone (PTH). The secondary outcome measures
will include: markers of bone formation (serum P1NP) and bone resorption (serum CTX).We will
also examine differences in serum 25(OH)D, PTH, and markers of bone turnover in African
American vs. Caucasian children.
the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian
children.
We propose a 6 month randomized placebo controlled trial of vitamin D (vitamin D3 1000
IU/day vs. placebo) initiated during October through March (during fall and winter) in 8 to
14 year old African American and Caucasian children. The results of the trial will help
establish the cutoff threshold value of serum 25(OH)D for defining vitamin D insufficiency
in preadolescent and adolescent children. Safety of vitamin D supplementation will be
assessed by measuring serum calcium at 0, 2 and 6 months and by monitoring for adverse
events. Currently recommended adequate intake for vitamin D of 200 IU daily may not meet the
body's daily needs for vitamin D. Therefore, it is likely that a higher level of daily
vitamin D intake may be needed to meet the body's skeletal and non-skeletal demands for
vitamin D. Determining the dietary required intake of vitamin D for the prevention of
vitamin D insufficiency during childhood has immense public health potential for addressing
health disparities and ensuring better bone health during adulthood. The primary outcome
measure will be serum 25(OH)D and parathyroid hormone (PTH). The secondary outcome measures
will include: markers of bone formation (serum P1NP) and bone resorption (serum CTX).We will
also examine differences in serum 25(OH)D, PTH, and markers of bone turnover in African
American vs. Caucasian children.
Epidemiologic and clinical data document a high prevalence of vitamin D insufficiency among
adults and adolescents in the US. Vitamin D insufficiency during childhood has the potential
to impact the acquisition of peak bone mass. Vitamin D insufficiency is also associated with
several non-skeletal disorders including cancer (prostate, breast, and colon), diabetes
mellitus (type 1 and type 2), and multiple sclerosis. In our pilot study nearly 50% of 6 to
10 year old African American children residing in Pittsburgh, Pennsylvania, were deemed
vitamin D insufficient (serum 25-hydroxyvitamin D (25(OH)D): ≤ 20 ng/mL; Rajakumar K, et al.
Clinical Pediatrics. 2005;44:683-692). To extend this field further, we are proposing a
randomized placebo-controlled trial of vitamin D3 for establishing the serum
25-hydroxyvitamin D (25(OH)D) cutoff threshold levels for defining vitamin D insufficiency
during childhood and to document the safety and efficacy of treatment on the vitamin D
status of the study cohort. A total of 168 (African American: 84, Caucasian: 84) 8 to 14
year old preadolescent and adolescent children will undergo a randomized-placebo controlled
trial (RCT) of vitamin D3 1000 IU daily vs. placebo for 6 months initiated during fall and
winter (October through March). Safety of vitamin D supplementation will be assessed by
measuring serum calcium at 0, 2 and 6 months and by monitoring for adverse events. We will
also examine the differences in serum 25(OH)D, PTH, and markers of bone turnover in African
American vs. Caucasian children. The primary outcome measure will be serum 25(OH)D and PTH.
The secondary outcome measures will include: markers of bone formation: serum osteocalcin
(OC) and bone resorption: serum C-terminal cross-linking telopeptide of type 1 collagen
(serum CTX). Additional outcomes will include: dietary intake of vitamin D and calcium, skin
color (Fitzpatrick Sunreactive Skin Type and Melanin Index), sun exposure, and body mass
index. Vitamin D deficiency will be defined as serum 25-hydroxyvitamin D concentrations <20
ng/mL. Public health importance of childhood vitamin D insufficiency is linked to the impact
of vitamin D status on the acquisition of peak bone mass. Reduced peak bone mass can
predispose to premature onset of osteoporosis and increase the risk for osteoporosis related
fragility fractures. Achieving and maintaining vitamin D sufficiency during childhood can
positively impact the skeletal health of children and reduce their "osteoporosis" burden
during adulthood, and modify their risk for the non-skeletal disorders associated with
chronic vitamin D insufficiency. Paucity of data regarding threshold levels of serum 25(OH)D
associated with vitamin D insufficiency status among school age children and the likelihood
that the serum 25(OH)D threshold levels for vitamin D sufficiency could be different among
African American and Caucasian children makes it compelling for this issue to be explored.
Based on expert opinion and supportive data in the medical literature, we feel that the
currently recommended adequate intake for vitamin D for pre- and adolescent children (200 IU
daily) is woefully inadequate to meet the daily needs for vitamin D. Therefore, it is likely
that a higher level of daily vitamin D intake may be needed to meet the body's skeletal and
non-skeletal demands for vitamin D. This study will determine the serum 25(OH)D cutoff for
the definition of vitamin D insufficiency and document the safety and efficacy of treatment
on vitamin D status.
adults and adolescents in the US. Vitamin D insufficiency during childhood has the potential
to impact the acquisition of peak bone mass. Vitamin D insufficiency is also associated with
several non-skeletal disorders including cancer (prostate, breast, and colon), diabetes
mellitus (type 1 and type 2), and multiple sclerosis. In our pilot study nearly 50% of 6 to
10 year old African American children residing in Pittsburgh, Pennsylvania, were deemed
vitamin D insufficient (serum 25-hydroxyvitamin D (25(OH)D): ≤ 20 ng/mL; Rajakumar K, et al.
Clinical Pediatrics. 2005;44:683-692). To extend this field further, we are proposing a
randomized placebo-controlled trial of vitamin D3 for establishing the serum
25-hydroxyvitamin D (25(OH)D) cutoff threshold levels for defining vitamin D insufficiency
during childhood and to document the safety and efficacy of treatment on the vitamin D
status of the study cohort. A total of 168 (African American: 84, Caucasian: 84) 8 to 14
year old preadolescent and adolescent children will undergo a randomized-placebo controlled
trial (RCT) of vitamin D3 1000 IU daily vs. placebo for 6 months initiated during fall and
winter (October through March). Safety of vitamin D supplementation will be assessed by
measuring serum calcium at 0, 2 and 6 months and by monitoring for adverse events. We will
also examine the differences in serum 25(OH)D, PTH, and markers of bone turnover in African
American vs. Caucasian children. The primary outcome measure will be serum 25(OH)D and PTH.
The secondary outcome measures will include: markers of bone formation: serum osteocalcin
(OC) and bone resorption: serum C-terminal cross-linking telopeptide of type 1 collagen
(serum CTX). Additional outcomes will include: dietary intake of vitamin D and calcium, skin
color (Fitzpatrick Sunreactive Skin Type and Melanin Index), sun exposure, and body mass
index. Vitamin D deficiency will be defined as serum 25-hydroxyvitamin D concentrations <20
ng/mL. Public health importance of childhood vitamin D insufficiency is linked to the impact
of vitamin D status on the acquisition of peak bone mass. Reduced peak bone mass can
predispose to premature onset of osteoporosis and increase the risk for osteoporosis related
fragility fractures. Achieving and maintaining vitamin D sufficiency during childhood can
positively impact the skeletal health of children and reduce their "osteoporosis" burden
during adulthood, and modify their risk for the non-skeletal disorders associated with
chronic vitamin D insufficiency. Paucity of data regarding threshold levels of serum 25(OH)D
associated with vitamin D insufficiency status among school age children and the likelihood
that the serum 25(OH)D threshold levels for vitamin D sufficiency could be different among
African American and Caucasian children makes it compelling for this issue to be explored.
Based on expert opinion and supportive data in the medical literature, we feel that the
currently recommended adequate intake for vitamin D for pre- and adolescent children (200 IU
daily) is woefully inadequate to meet the daily needs for vitamin D. Therefore, it is likely
that a higher level of daily vitamin D intake may be needed to meet the body's skeletal and
non-skeletal demands for vitamin D. This study will determine the serum 25(OH)D cutoff for
the definition of vitamin D insufficiency and document the safety and efficacy of treatment
on vitamin D status.
Inclusion Criteria:
- Age: 8-14 years
- Race: African American or Caucasian
- Children not taking multivitamins for at least 1 month before enrollment and agree
not to start any multivitamin supplements during the 6-month trial period.
- Children who are on multivitamins can be considered for enrollment only if they are
able to and agree to stop their multivitamin tablet for a 1 month washout period
prior to enrollment.
- Absence of chronic diseases that could affect growth or calcium or vitamin D
metabolism
Exclusion Criteria:
- Hepatic or renal disease
- Metabolic rickets
- Malabsorptive disorders (Crohn's disease, cystic fibrosis and celiac disease) or
cancer
- Treatment with anticonvulsants or systemic glucocorticoids
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