title: A 7-Year Longitudinal Trial of the Safety and Efficacy of a Vitamin/Mineral Enhanced Plant-Sourced Calcium Supplement.
abstract: OBJECTIVE
  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.
authors.affiliation: a Integrative Health Technologies, Inc. , San Antonio , Texas (G.R.K.).
authors.forename: Gilbert R
authors.initials: GR
authors.lastname: Kaats
authors.affiliation: b Department of Biochemistry , Georgetown University Medical Center , Washington , DC (H.G.P.).
authors.forename: Harry G
authors.initials: HG
authors.lastname: Preuss
authors.affiliation: c Creighton University , Frisco , Texas (S.S.).
authors.forename: Sidney
authors.initials: S
authors.lastname: Stohs
authors.affiliation: d Transdermal Biotechnology, Inc. , Meriden , Connecticut (N.P.).
authors.forename: Nicholas
authors.initials: N
authors.lastname: Perricone
mesh_terms: D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D002118:Calcium / Q000008:administration & dosage* / Q000494:pharmacology* / Q000627:therapeutic use; D019587:Dietary Supplements / Q000032:analysis*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage / Q000627:therapeutic use; D010024:Osteoporosis / Q000517:prevention & control*; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D008903:Minerals; D014815:Vitamins; D002118:Calcium
keywords: AlgaeCal; body composition; bone mineral density