A Prospective Study of Commonly Utilized Regimens of Vitamin d Replacement and Maintenance Therapy in Adults

Rafii, Daniel C.; Ali, Farah; Farag, Amal; Iyer, Bhanu; Otterbeck, Philip; Chaudhari, Ronak; Potter, Natia; Stefanov, Dimitre; Guber, Helena A.

doi:10.4158/ep-2018-0219

Cited by 3 publications

(36 citation statements)

References 21 publications

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“…They also contradict findings from another prospective study that recruited 100 participants randomized to receive one of four regimens: cholecalciferol (D3) 2,000 international units (IU) daily, D3 3,000 IU daily, ergocalciferol (D2) 50,000 IU weekly, and D2 50,000 IU twice weekly. All groups achieved mean 25(OH)D levels > 30 ng/mL (>75 nmol/L) by five months [18].…”

Section: Discussionmentioning

confidence: 93%

“…The fourth intervention was the most efficacious in achieving and maintaining a 25(OH)D level > 30 mg/mL (75 nmol/L) for 12 months. Notably, the average 25(OH)D level in the fourth group remained >50 ng/mL (125 nmol/L) for nearly nine months, without adverse effects [18].…”

Section: Introductionmentioning

confidence: 94%

“…An American retrospective chart review study conducted in patients over a period of six years from January 2001 to May 2007 in adults demonstrated that, after completion of the therapeutic regimen, maintenance therapy of 50,000 IU ergocalciferol every other week for up to six years successfully maintained vitamin D levels without adverse effects [17]. Another retrospective study suggested that 50,000 IU vitamin D2 once weekly for eight weeks followed by 50,000 IU every other week for another 3-4 months may be an acceptable maintenance regimen [18]. A prospective study was conducted of the New York Harbor-Healthcare System over a one-year period on commonly used regimens for treating and maintaining normal serum levels of vitamin D. The study included 100 adult patients with a low serum level of vitamin D (<75 nmol/L), who were randomized equally to four groups.…”

Section: Introductionmentioning

confidence: 99%

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Effect of Monthly and Bi-Monthly 50,000 International Units (IU) Maintenance Therapy With Vitamin D3 on Serum Level of 25-Hydroxyvitamin D in Adults: A Randomized Controlled Trial

AlAteeq¹,

AlShail²,

ALZAHRANI³

et al. 2021

Cureus

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Background Vitamin D deficiency is a prevalent condition worldwide. Identification of optimal supplementation approaches for maintaining normal vitamin D level in healthy adults is still required. It has been clearly established that sun exposure and diet do not provide the recommended daily amount of vitamin D, and that vitamin D supplementation is needed to maintain normal levels in the Saudi population. The aim of this study was to compare the efficacy of two regimens, monthly and bimonthly doses of 50,000 International Units (IU) cholecalciferol (vitamin D3), in maintaining normal serum levels of 25-hydroxyvitamin D in Saudi adults. Methods This study was a randomized controlled trial conducted to compare the efficacy of three regimens in maintaining a normal level of vitamin D in adult individuals. The study took place at three primary healthcare centers in King Abdul-Aziz Medical City, Riyadh, Saudi Arabia. A total of 65 participants were enrolled and randomly divided into two intervention groups and one control group. All participants were contacted by researchers and followed up at their corresponding primary health care center for two successive visits. Results All 65 participants completed the study. The participants were mostly females (49; 75.4%); the mean age was 42.1 years (±13.5). The difference in vitamin D levels after three months of the trial was statistically significant among the three groups. A decrease in vitamin D level was recorded in the control group and in the once monthly intake of 50,000 IU group. The bimonthly intake of 50,000 IU group maintained statistically significant vitamin D levels > 75. Conclusion Bimonthly vitamin D3 supplementation appears to be an efficient regimen for maintaining a normal level of 25(OH)D, regardless of the amount of vitamin D obtained from diet and sun exposure.

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Section: Discussionmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

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Effect of Monthly and Bi-Monthly 50,000 International Units (IU) Maintenance Therapy With Vitamin D3 on Serum Level of 25-Hydroxyvitamin D in Adults: A Randomized Controlled Trial

AlAteeq¹,

AlShail²,

ALZAHRANI³

et al. 2021

Cureus

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“…Highest vitamin D dose administered ranged from 100 µg/d (Hin et al 2016; to 357 µg/d (Rafii et al 2019), and one RCT used a mega dose of 2500 µg/d (Brohult et al 1973).…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Seven RTCs reported on the use of calcium as a co-intervention (Aloia et al 2013;Aloia et al 2018;Billington et al 2020;Gallagher et al 2012;Mastaglia et al 2006;Rafii et al 2019;Vieth et al 2001). Highest vitamin D dose administered ranged from 100 µg/d (Aloia et al 2013;Ceglia et al 2013;Johnson et al 2022;Rorie et al 2014) to 357 µg/d (Aloia et al 2018;Billington et al 2020;Mastaglia et al 2006;Rafii et al 2019).…”

Section: Study Characteristicsmentioning

confidence: 99%

Preparatory work for the update of the tolerable upper intake levels for vitamin D

Lamberg‐Allardt

Adebayo

Peltonen

et al. 2023

EFSA Supporting Publications

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This technical report describes the collection of data and appraisal of scientific evidence in relation to the assessment of Tolerable Upper Intake Levels (UL) for vitamin D. Five systematic reviews (SR) were conducted following a tailored literature search, data extraction, evidence appraisal (i.e., risk of bias (RoB) assessment) and evidence synthesis. Narrative reviews were conducted to gather contextual evidence relevant to the interpretation of the main body of evidence (BoE). In the SR on bioavailability of calcidiol compared to native vitamin D3, 4304 records were identified and reduced to 12 individual records after screening for eligibility. The evidence appraisal revealed an overall low to high RoB of the individual studies. The available BoE demonstrated higher relative bioavailability of calcidiol compared to native vitamin D3 with a conversion factor of about 2 across baseline 25(OH)D concentrations of 30 to 55 nmol/L. In the SR on hypercalcaemia and hypercalciuria, 8277 records were identified and reduced to 37 individual records after screening for eligibility. The evidence appraisal revealed an overall low to high RoB of the individual studies. The available evidence demonstrated that occurrence of persistent hypercalcemia and hypercalciuria with high doses of vitamin D supplementation was rare. Nevertheless, increased risk of persistent hypercalciuria was observed with 250 μg/d of vitamin D supplementation. In the SRs on bone fractures, falls, bone mineral density (BMD), bone mineral content, and bone strength, 15 541 records were identified and reduced to 20 individual records after screening for eligibility. The evidence appraisal revealed an overall low to moderate RoB of the individual studies. No clear signs of adverse effects of high vitamin D intake were found in relation to bone fractures, falls, or areal BMD, but volumetric BMD was reduced with 100 and 250 μg/d of vitamin D.

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Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate

Turck¹,

Bohn²,

Castenmiller³

et al. 2023

EFS2

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Following two requests from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for vitamin D and to propose a conversion factor (CF) for calcidiol monohydrate into vitamin D 3 for labelling purposes. Vitamin D refers to ergocalciferol (vitamin D 2 ), cholecalciferol (vitamin D 3 ), and calcidiol monohydrate. Systematic reviews of the literature were conducted to assess the relative bioavailability of calcidiol monohydrate versus vitamin D 3 on serum 25(OH)D concentrations, and for priority adverse health effects of excess vitamin D intake, namely persistent hypercalcaemia/hypercalciuria and endpoints related to musculoskeletal health (i.e. falls, bone fractures, bone mass/density and indices thereof). Based on the available evidence, the Panel proposes a CF for calcidiol monohydrates of 2.5 for labelling purposes. Persistent hypercalciuria, which may be an earlier sign of excess vitamin D than persistent hypercalcaemia, is selected as the critical endpoint on which to base the UL for vitamin D. A lowest-observed-adverse-effect-level (LOAEL) of 250 μg/day is identified from two randomised controlled trials in humans, to which an uncertainty factor of 2.5 is applied to account for the absence of a no-observed-adverse-effect-level (NOAEL). A UL of 100 μg vitamin D equivalents (VDE)/day is established for adults (including pregnant and lactating women) and for adolescents aged 11-17 years, as there is no reason to believe that adolescents in the phase of rapid bone formation and growth have a lower tolerance for vitamin D compared to adults. For children aged 1-10 years, a UL of 50 μg VDE/day is established by considering their smaller body size. Based on available intake data, European populations are unlikely to exceed the UL, except for regular users of food supplements containing high doses of vitamin D.

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A Prospective Study of Commonly Utilized Regimens of Vitamin d Replacement and Maintenance Therapy in Adults

Cited by 3 publications

References 21 publications

Effect of Monthly and Bi-Monthly 50,000 International Units (IU) Maintenance Therapy With Vitamin D3 on Serum Level of 25-Hydroxyvitamin D in Adults: A Randomized Controlled Trial

Effect of Monthly and Bi-Monthly 50,000 International Units (IU) Maintenance Therapy With Vitamin D3 on Serum Level of 25-Hydroxyvitamin D in Adults: A Randomized Controlled Trial

Preparatory work for the update of the tolerable upper intake levels for vitamin D

Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate

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