Effect of vitamin D replacement on indexes of insulin resistance in overweight elderly individuals: a randomized controlled trial

Fuleihan, G. El Hajj; Baddoura, Rafic; Habib, Robert H.; Halaby, Georges; Arabi, Asma; Rahme, Maya; Singh, Ravinder J.; Kassem, Moustapha; Mahfoud, Ziyad; Hoteit, Maha; Daher, Rose T.; Kassir, Mohamed Faisal

doi:10.3945/ajcn.116.132589

Cited by 33 publications

(38 citation statements)

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“…A total of 35 subjects, 14% of original randomized cohort, did not complete the study; the dropout rate was similar in both groups, most of it occurred early in the study, and was in large part due to patients having changed their mind about study participation (Fig. ) . Two patients died, one in each treatment group.…”

Section: Resultsmentioning

confidence: 99%

“…The trial had two primary outcomes, indices of insulin resistance at 12 months, recently reported, and of bone metabolism at 12 months reported herein (BMD and bone remodeling)…”

Section: Methodsmentioning

confidence: 99%

“…Allowing for a possible estimated dropout rate of 30%, we would need 75 subjects per arm. However, we enrolled 257 subjects to accommodate the larger sample size calculation requirements for the other primary outcome of insulin resistance …”

Section: Methodsmentioning

confidence: 99%

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Impact of Calcium and Two Doses of Vitamin D on Bone Metabolism in the Elderly: A Randomized Controlled Trial

Rahme

Sharara

Baddoura

et al. 2017

Journal of Bone and Mineral Research

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The optimal dose of vitamin D to optimize bone metabolism in the elderly is unclear. We tested the hypothesis a vitamin D, at a dose higher than recommended by the Institute of Medicine (IOM), has a beneficial effect on bone remodeling and mass. In this double blind trial we randomized 257 overweight elderly subjects to receive 1000 mg of elemental calcium citrate/day, and the daily equivalent of 3,750IU/day or 600 IU/day of vitamin D3 for one year. The subjects’ mean age was 71±4 years, body mass index 30±4 kg/m2, 55% were women, and 222 completed the 12-months follow-up. Mean serum 25 hydroxy-vitamin D (25OHD) was 20 ng/ml, and rose to 26 ng/ml in the low dose, and 36ng/ml in the high dose arm, at one year (p<0.05). Plasma parathyroid hormone, osteocalcin, and C-terminal telopeptide (Cross Laps) levels decreased significantly by 20–22% in both arms, but there were no differences between the two groups for any variable, at 6 or 12 months, with the exception of serum calcitriol that was higher in the high-dose group at 12 months. Bone mineral density (BMD) increased significantly at total hip and lumbar spine, but not femoral neck, in both arms, while subtotal body BMD increased in the high-dose group only, at one year. However, there were no significant differences in percent change BMD between the 2 arms at any skeletal site. Subjects with serum 25OHD below 20 ng/ml and PTH level above 76 pg/ml, showed a trend for higher BMD increments at all skeletal sites, in the high-dose group, that reached significance at the hip. Adverse events were comparable in the two study arms. This controlled trial demonstrates little additional benefit in vitamin D supplementation at a dose exceeding the IOM recommendation of 600IU/day on BMD and bone markers, in overweight elderly individuals.

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Section: Resultsmentioning

confidence: 99%

“…The trial had two primary outcomes, indices of insulin resistance at 12 months, recently reported, and of bone metabolism at 12 months reported herein (BMD and bone remodeling)…”

Section: Methodsmentioning

confidence: 99%

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Impact of Calcium and Two Doses of Vitamin D on Bone Metabolism in the Elderly: A Randomized Controlled Trial

Rahme

Sharara

Baddoura

et al. 2017

Journal of Bone and Mineral Research

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“…Although mixed, there is evidence linking elevated serum PTH and lower 25OHD to a variety of negative health outcomes in both men and women [43,44,45,46,47,48,49,50,51,52]. Some researchers hypothesize excess PTH secretion to be involved in the development of hypertension, a theory supported by data indicating a positive correlation between blood pressure and serum concentrations of PTH [53,54,55].…”

Section: Discussionmentioning

confidence: 99%

“…In several large community based cohort studies, low serum 25OHD levels have not shown to be associated with poor CVD outcomes [45,47]. The relationship of low serum 25OHD levels and insulin resistance and metabolic syndrome has been more consistently reported [48,49], although prospective studies do not always suggest improvements in insulin sensitivity with improvements in vitamin D status [50,51]. Whether or not the dosages used in these studies and effective in raising serum 25OHD levels is often debated.…”

Section: Discussionmentioning

confidence: 99%

Serum Parathyroid Hormone Responses to Vitamin D Supplementation in Overweight/Obese Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

et al. 2017

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Obesity is often associated with vitamin D deficiency and secondary hyperparathyroidism. Vitamin D supplementation typically leads to the reductions in serum parathyroid hormone (PTH) levels, as shown in normal weight individuals. Meanwhile, the dose of vitamin D supplementation for the suppression of PTH may differ in overweight and obese adults. We conducted a systematic review and meta-analysis of randomized controlled trials to determine the dose of vitamin D supplementation required to suppress PTH levels in overweight/obese individuals. We identified 18 studies that examined overweight or obese healthy adults who were supplemented with varying doses of vitamin D3. The primary outcomes examined were changes in PTH and serum 25-hydroxyvitamin D (25OHD) levels from baseline to post-treatment. The results of the meta-analysis showed that there was a significant treatment effect of vitamin D supplementation on PTH, total standardized mean difference (SMD) (random effects) = −0.38 (95% CI = −0.56 to −0.20), t = −4.08, p < 0.001. A significant treatment effect of vitamin D supplementation was also found on 25OHD, total SMD (random effects) = 2.27 (95% CI = 1.48 to 3.06) t = 5.62, p < 0.001. Data from available clinical trials that supplemented adults with D3 ranging from 400 IU to 5714 IU, showed that 1000 IU of vitamin D supplementation best suppressed serum PTH levels, total SMD = −0.58, while vitamin D supplementation with 4000 IU showed the greatest increase in serum 25OH levels. Vitamin D and calcium supplementation of 700 IU and 500 mg, respectively, also showed a significant treatment effect on the suppression of PTH with a total SMD = −5.30 (95% CI = −9.72 to −0.88). In conclusion, the meta analysis of available clinical trials indicates that 1000 IU vitamin D supplementation can suppress serum PTH levels, while 4000 IU of vitamin D was associated with the largest increase in serum 25OHD levels in the overweight and obese population.

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Vitamin D Deficiency

McKenna

Kilbane

2022

Endocrinology and Diabetes

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Effect of vitamin D replacement on indexes of insulin resistance in overweight elderly individuals: a randomized controlled trial

Abstract: Vitamin D3 at 3750 IU/d did not improve HOMA-IR compared with the Institute of Medicine Recommended Dietary Allowance of 600 IU/d in elderly overweight individuals. This trial was registered at clinicaltrials.gov as NCT01315366.

Cited by 33 publications

References 46 publications

Impact of Calcium and Two Doses of Vitamin D on Bone Metabolism in the Elderly: A Randomized Controlled Trial

Impact of Calcium and Two Doses of Vitamin D on Bone Metabolism in the Elderly: A Randomized Controlled Trial

Serum Parathyroid Hormone Responses to Vitamin D Supplementation in Overweight/Obese Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Vitamin D Deficiency

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