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

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

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Bone Density / drug effects*
  • Calcium / administration & dosage*
  • Calcium / pharmacology*
  • Calcium / therapeutic use
  • Dietary Supplements / analysis*
  • Drug Administration Schedule
  • Female
  • Humans
  • Longitudinal Studies
  • Middle Aged
  • Minerals / administration & dosage
  • Minerals / therapeutic use
  • Osteoporosis / prevention & control*
  • Vitamins / administration & dosage*

Substances

  • Minerals
  • Vitamins
  • Calcium