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J Am Coll Nutr. 2016;35(2):91-9. doi: 10.1080/07315724.2015.1090357. Epub 2016 Feb 17.

A 7-Year Longitudinal Trial of the Safety and Efficacy of a Vitamin/Mineral Enhanced Plant-Sourced Calcium Supplement.

Author information

1
a Integrative Health Technologies, Inc. , San Antonio , Texas (G.R.K.).
2
b Department of Biochemistry , Georgetown University Medical Center , Washington , DC (H.G.P.).
3
c Creighton University , Frisco , Texas (S.S.).
4
d Transdermal Biotechnology, Inc. , Meriden , Connecticut (N.P.).

Erratum in

Abstract

OBJECTIVES:

The objective of this study was to examine the safety and efficacy of a vitamin-mineral enhanced plant-sourced calcium AlgaeCal calcium (AC) in female consumers who had taken the supplement from 1 to 7 years.

METHODS:

Consumers who had completed at least one dual-energy x-ray absorptiometry (DEXA) bone mineral density (BMD) scan (N = 172) and/or blood chemistry test (N = 30) and purchased AC from 1 to 7 years were contacted and offered complimentary repeat tests. Safety and efficacy were examined by annualized changes in a 45-measurement blood chemistry panel and changes in BMD.

RESULTS:

No adverse effects or safety concerns were found in any of the annualized within-group annualized changes in the 45 blood chemistries or in between-group changes in a similar control group (n = 5070) who completed the same measurements. With regard to BMD, consistent and statistically significant within-group increases were found for the 7-year study period and when compared to expected BMD changes in 3 large databases or the combination (N = 25,885) of the 3 databases. Data from this study suggest that AC supplement was associated with a significant annualized and linear increase in BMD of 1.04% per year, 7.3% over the 7-year study period. These results stand in marked contrast to normative or expected changes of -0.4%/y from 3 different databases or in a combination of all 3 databases (N = 16,289).

CONCLUSIONS:

No evidence was found in cardiovascular risk as measured by adverse changes in blood lipids, nor was any evidence found of a diminished efficacy over the 7-year study period because gains in BMD were consistent and linear over the 7-year study period, averaging 1.04% per year over the 7-year study. The results are also consistent with earlier short-term studies suggesting that this supplement can facilitate significant increases in total body BMD in contrast to studies suggesting that calcium supplements can only slow down age-related declines in BMD.

KEYWORDS:

AlgaeCal; body composition; bone mineral density

PMID:
26885697
DOI:
10.1080/07315724.2015.1090357
[Indexed for MEDLINE]

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