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Efficacy and tolerability of calcium, vitamin D and a plant-based omega-3 oil for osteopenia: a pilot RCT.

Maturitas
January 1, 2012
Simon J Vanlint et al. (2 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to test the efficacy, acceptability, and tolerability of calcium and vitamin D supplementation, with or without DHA, in individuals with osteopenia.

Results Summary

The combination of calcium, vitamin D, and DHA was safe and tolerable, with a positive effect on bone health indicated by suppressed CTx levels. Changes in BMD at the lumbar spine and total proximal femur correlated significantly with CTx changes, though DHA addition showed no additional effect.

Population

Individuals with osteopenia

Effective Dosage

1200 mg calcium carbonate with 1000 IU vitamin D₃ daily

Duration

12 months

Interactions

None mentioned

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
algal oil containing 400mg docosahexanoic acid (DHA) daily
no change
serum c-terminal telopeptides (CTx)
individuals with osteopenia
-
no difference in effect size
#1
algal oil containing 400mg docosahexanoic acid (DHA) daily
no change
bone health
individuals with osteopenia
-
no effect demonstrated
#2
1200 mg calcium carbonate with vitamin D(3) 1000 IU daily
decrease
Mean CTx
individuals with osteopenia
-
suppressed
#3
oral calcium, vitamin D(3) and DHA
neutral
-
osteopenic individuals
-
safe, tolerable and acceptable
#4
oral calcium, vitamin D(3) and DHA
increase
bone health
osteopenic individuals
-
positive effect
#5
-
neutral
Changes in CTx
-
-
significantly correlated
#6
-
neutral
Changes in BMD at the lumbar spine
-
-
significantly correlated
#7
-
neutral
Changes in BMD at the total proximal femur (TPF)
-
-
significantly correlated
#8
-
increase
BMD
-
-
non-significant trend towards rising
#9
Abstract

OBJECTIVES: Our pilot study tested the efficacy, acceptability and tolerability of DHA supplementation in addition to calcium and vitamin D in individuals with osteopenia. STUDY DESIGN: 40 participants were randomised to either algal oil containing 400mg docosahexanoic acid (DHA) daily or placebo. All participants received 1200 mg calcium carbonate with vitamin D(3) 1000 IU daily. MAIN OUTCOME MEASURES: Bone mineral density (BMD) was measured at baseline and 12 months. Bone turnover was assessed with serum c-terminal telopeptides (CTx) at baseline and 12 months. Tolerability and acceptability were assessed using a validated questionnaire. RESULTS: Mean CTx was suppressed after 12 months for all participants (p=0.04) with no difference in effect size between DHA and control groups (p=0.53). Changes in CTx at 12 months were significantly correlated with changes in BMD at the lumbar spine (p=0.01) and total proximal femur (TPF) (p=0.03). There was a non-significant trend towards rising BMD at 12 months. Participants rated the supplements as tolerable and acceptable, with few adverse events. CONCLUSIONS: The combination of oral calcium, vitamin D(3) and DHA was safe, tolerable and acceptable when used for 12 months by osteopenic individuals in this pilot study. The combination had a positive effect on bone health as indicated by serum CTx, with no effect demonstrated from the addition of DHA 400mg. Changes in BMD at the lumbar spine and TPF were significantly correlated with changes in CTx, which may be useful in monitoring bone health and response to treatment.

Medical Subject Headings (MeSH)
Bone DensityBone Density Conservation AgentsBone Diseases, MetabolicCalciumCalcium CarbonateCholecalciferolDietary SupplementsDocosahexaenoic AcidsDrug Therapy, CombinationFemaleFemurHumansLumbar VertebraeMaleMiddle AgedPatient SatisfactionPeptidesPilot ProjectsTreatment Outcome
Study Links
Quality Scores
Safety90
Efficacy75/10
Quality80/10
Citation Metrics
Total Citations15
Citations/Year1.2
Relative Citation Ratio0.57
NIH Percentile31%
Research Impact Scores
APT Score0.50
Weight Score1.40
Normalized Score0.82
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