title: Feasibility of a clinical trial to assess the effect of dietary calcium v. supplemental calcium on vascular and bone markers in healthy postmenopausal women.
abstract: Whether supplemental Ca has similar effects to dietary Ca on vascular and bone markers is unknown. The present trial investigated the feasibility of applying dietary and supplemental interventions in a randomised-controlled trial (RCT) aiming to estimate the effect of supplemental Ca as compared with dietary Ca on vascular and bone markers in postmenopausal women. In total, thirteen participants were randomised to a Ca supplement group (CaSuppl) (750 mg Ca from CaCO3+450 mg Ca from food+20 µg vitamin D supplement) or a Ca diet group (CaDiet) (1200 mg Ca from food+10 µg vitamin D supplement). Participants were instructed on Ca consumption targets at baseline. Monthly telephone follow-ups were conducted to assess adherence to interventions (±20 % of target total Ca) using the multiple-pass 24-h recall method and reported pill count. Measurements of arterial stiffness, peripheral blood pressure and body composition were performed at baseline and after 6 and 12 months in all participants who completed the trial (n 9). Blood and serum biomarkers were measured at baseline and at 12 months. Both groups were compliant to trial interventions (±20 % of target total Ca intake; pill count ≥80 %). CaSuppl participants maintained a significantly lower average dietary Ca intake compared with CaDiet participants throughout the trial (453 (sd 187) mg/d v. 1241 (sd 319) mg/d; P<0·001). There were no significant differences in selected vascular outcomes between intervention groups over time. Our pilot trial demonstrated the feasibility of conducting a large-scale RCT to estimate the differential effects of supplemental and dietary Ca on vascular and bone health markers in healthy postmenopausal women.
authors.affiliation: 1Research Institute,McGill University Health Centre,Montreal,QC,Canada,H3G 1A4.
authors.forename: Angel M
authors.identifier: 0000-0001-8107-5976
authors.initials: AM
authors.lastname: Ong
authors.affiliation: 2School of Dietetics and Human Nutrition,McGill University,Ste-Anne-de-Bellevue,QC,Canada,H9X 3V9.
authors.forename: Hope A
authors.initials: HA
authors.lastname: Weiler
authors.affiliation: 1Research Institute,McGill University Health Centre,Montreal,QC,Canada,H3G 1A4.
authors.forename: Michelle
authors.initials: M
authors.lastname: Wall
authors.affiliation: 3Department of Nutrition,Shriners Children's Hospital,Montreal,QC,Canada,H3G 1A6.
authors.forename: Rouba
authors.initials: R
authors.lastname: Haddad
authors.affiliation: 1Research Institute,McGill University Health Centre,Montreal,QC,Canada,H3G 1A4.
authors.forename: Jessica
authors.initials: J
authors.lastname: Gorgui
authors.affiliation: 1Research Institute,McGill University Health Centre,Montreal,QC,Canada,H3G 1A4.
authors.forename: Stella S
authors.identifier: 0000-0003-4774-2549
authors.initials: SS
authors.lastname: Daskalopoulou
authors.affiliation: 1Research Institute,McGill University Health Centre,Montreal,QC,Canada,H3G 1A4.
authors.forename: David
authors.identifier: 0000-0003-3421-7147
authors.initials: D
authors.lastname: Goltzman
authors.affiliation: 1Research Institute,McGill University Health Centre,Montreal,QC,Canada,H3G 1A4.
authors.forename: Suzanne N
authors.initials: SN
authors.lastname: Morin
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D001842:Bone and Bones / Q000378:metabolism*; D002119:Calcium Carbonate / Q000008:administration & dosage / Q000494:pharmacology*; D002136:Calcium, Dietary / Q000494:pharmacology*; D002318:Cardiovascular Diseases / Q000097:blood / Q000378:metabolism / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause
chemical_list: D015415:Biomarkers; D002136:Calcium, Dietary; D002119:Calcium Carbonate
keywords: 25(OH)D 25-hydroxy vitamin D; Arterial stiffness; CaDiet Ca diet group; CaSuppl Ca supplement group; Calcium; Dietary interventions; PTH parathyroid hormone; PWV pulse wave velocity; Postmenopausal women; cfPWV carotid-femoral pulse wave velocity; crPWV carotid-radial pulse wave velocity