Michael L Traub1, John S Finnell, Anup Bhandiwad, Erica Oberg, Lena Suhaila, Ryan Bradley. 1. Lokahi Health Center (M.L.T.), Kailua Kona, Hawaii 96740; AOMA Graduate School of Integrative Medicine, (J.S.F.) Austin, Texas 78745; Wayne State University (A.B.), Detroit, Michigan 48202; Pacific Pearl Center for Health and Healing (E.O.), La Jolla, California 92037; Cancer Treatment Centers of America Western Regional Medical Center (L.S.), Phoenix, Arizona 85338; and Bastyr University Research Institute (R.B.), San Diego, California 98028.
Abstract
CONTEXT: As a result of research suggesting increased health risk with low serum 25-hydroxycholecalciferol (25(OH)D), health care providers are measuring it frequently. Providers and patients are faced with treatment choices when low status is identified. OBJECTIVE: To compare the safety and efficacy of three vitamin D3 dietary supplements with different delivery matrices. SETTING AND DESIGN: A 12-week, parallel group, single-masked, clinical trial was conducted in Seattle, Washington and Kailua Kona, Hawaii. Sixty-six healthy adults with (25(OH)D) <33 ng/mL were randomly assigned to take one of three D3 supplements, ie, a chewable tablet (TAB), an oil-emulsified drop (DROP), or an encapsulated powder (CAP) at a label-claimed dose of 10,000 IU/day. Actual D3 content was assessed by a third party and the results adjusted based on the actual D3 content administered. Mean change in 25(OH)D/mcg D3 administered; difference in the proportion of D3 insufficient participants (ie, 25(OH)D ≤30 ng/mL) reaching sufficiency (ie, 25(OH)D ≥30 ng/mL); and mean change in serum 1, 25-dihydroxycholecalciferol were measured. RESULTS: In two of the three products tested, the measured vitamin D3 content varied considerably from the label-claimed dose. Differences in 25(OH)D/mcg D3 administered were significantly different between groups (P = .04; n = 55). Pairwise comparisons demonstrated DROP resulted in a greater increase than TAB (P < .05) but not than CAP. TAB was not different from CAP. The proportions reaching sufficiency were: 100% (TAB and CAP) and 80% (DROP) (P = .03 between groups; n = 55). 1, 25-Dihydroxycholecalciferol did not change significantly in any group. CONCLUSIONS:Oil-emulsified vitamin D3 supplements resulted in a greater mean change in serum 25(OH)D concentration, but fewer patients reaching vitamin D sufficiency, than chewable or encapsulated supplements.
RCT Entities:
CONTEXT: As a result of research suggesting increased health risk with low serum 25-hydroxycholecalciferol (25(OH)D), health care providers are measuring it frequently. Providers and patients are faced with treatment choices when low status is identified. OBJECTIVE: To compare the safety and efficacy of three vitamin D3 dietary supplements with different delivery matrices. SETTING AND DESIGN: A 12-week, parallel group, single-masked, clinical trial was conducted in Seattle, Washington and Kailua Kona, Hawaii. Sixty-six healthy adults with (25(OH)D) <33 ng/mL were randomly assigned to take one of three D3 supplements, ie, a chewable tablet (TAB), an oil-emulsified drop (DROP), or an encapsulated powder (CAP) at a label-claimed dose of 10,000 IU/day. Actual D3 content was assessed by a third party and the results adjusted based on the actual D3 content administered. Mean change in 25(OH)D/mcg D3 administered; difference in the proportion of D3 insufficient participants (ie, 25(OH)D ≤30 ng/mL) reaching sufficiency (ie, 25(OH)D ≥30 ng/mL); and mean change in serum 1, 25-dihydroxycholecalciferol were measured. RESULTS: In two of the three products tested, the measured vitamin D3 content varied considerably from the label-claimed dose. Differences in 25(OH)D/mcg D3 administered were significantly different between groups (P = .04; n = 55). Pairwise comparisons demonstrated DROP resulted in a greater increase than TAB (P < .05) but not than CAP. TAB was not different from CAP. The proportions reaching sufficiency were: 100% (TAB and CAP) and 80% (DROP) (P = .03 between groups; n = 55). 1, 25-Dihydroxycholecalciferol did not change significantly in any group. CONCLUSIONS:Oil-emulsified vitamin D3 supplements resulted in a greater mean change in serum 25(OH)D concentration, but fewer patients reaching vitamin D sufficiency, than chewable or encapsulated supplements.
Authors: Robert P Heaney; K Michael Davies; Tai C Chen; Michael F Holick; M Janet Barger-Lux Journal: Am J Clin Nutr Date: 2003-01 Impact factor: 7.045
Authors: Diana L Ersfeld; D Sudhaker Rao; Jean-Jacques Body; James L Sackrison; Andrew B Miller; Nayana Parikh; Tar Lisha Eskridge; Amy Polinske; Gregory T Olson; Gordon D MacFarlane Journal: Clin Biochem Date: 2004-10 Impact factor: 3.281
Authors: Josephia R Muindi; Araba A Adjei; Zengru R Wu; Isabel Olson; Huayi Huang; Adrienne Groman; Lili Tian; Prashant K Singh; Lara E Sucheston; Candace S Johnson; Donald L Trump; Marwan G Fakih Journal: Horm Cancer Date: 2013-02-28 Impact factor: 3.869