Evidence map›Paper›PMID 27413130›Full record

Trial reportThe American journal of clinical nutrition2016

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

Ghada El-Hajj Fuleihan, Rafic Baddoura, Robert H Habib, Georges Halaby, Asma Arabi, Maya Rahme, Ravinder J Singh, Moustapha Kassem, Ziyad Mahfoud, Maha Hoteit and 2 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of clinical nutrition, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01315366 (Phase III Study on the Effect of Vitamin D Supplementation on Indices of Mineral and Musculoskeletal Metabolism and on Parameters of Glucose and Fuel Metabolism in Elderly Subjects), which is not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
4.2field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01315366 phase3completednot on this map

Phase III Study on the Effect of Vitamin D Supplementation on Indices of Mineral and Musculoskeletal Metabolism and on Parameters of Glucose and Fuel Metabolism in Elderly Subjects

TypeinterventionalSponsorAmerican University of Beirut Medical CenterRan2011 to 2015Enrolled257ConditionsHypovitaminosis D, Insulin Resistance, Obesity, OsteoporosisArmsEuro D and Ci-CalD, Euro D, Ci-CalD
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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  4. Impact of vitamin D replacement in adults and elderly in the Middle East and North Africa: a systematic review and meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017
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  9. Impact of Calcium and Two Doses of Vitamin D on Bone Metabolism in the Elderly: A Randomized Controlled Trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2017
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 4 countries.

Ghada El-Hajj FuleihanDivision of Endocrinology, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center, Beirut, Lebanon; gf01@aub.edu.lb.ORCID http://orcid.org/0000-0002-2076-5858
Rafic BaddouraDepartments of Rheumatology and.
Robert H HabibDepartments of Internal Medicine and.
Georges HalabyEndocrinology, Hȏtel-Dieu de France, Beirut, Lebanon;
Asma ArabiDivision of Endocrinology, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center, Beirut, Lebanon;
Maya RahmeDivision of Endocrinology, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center, Beirut, Lebanon;
Ravinder J SinghDivision of Clinical Biochemistry and Immunology, Mayo Clinic, Rochester, MN;
Moustapha KassemDepartment of Endocrinology and Metabolism, Odense University Hospital, Odense, Denmark; and.
Ziyad MahfoudDepartment of Health Policy and Research, Weill Cornell Medical College, Doha, Qatar.
Maha HoteitDivision of Endocrinology, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center, Beirut, Lebanon;
Rose T DaherPathology and Laboratory Medicine and.
Mohamed-Faisal KassirDivision of Endocrinology, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center, Beirut, Lebanon;
American University of Beirut Medical Center · LBHôtel-Dieu de France · LBMayo Clinic · USOdense University Hospital · DKWeill Cornell Medical College in Qatar · QA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt is unclear whether and at what dose vitamin D supplementation affects insulin resistance (IR).

objectiveWe sought to investigate whether vitamin D at doses higher than currently recommended decreases indexes of IR in an ambulatory population of overweight elderly subjects.

designThis double-blind, randomized, controlled multicenter trial enrolled 257 elderly overweight individuals aged ≥65 y with baseline 25-hydroxyvitamin D [25(OH)D] concentrations between 10 and 30 ng/mL. All subjects received 1000 mg calcium citrate/d, with vitamin D administered weekly at an equivalent dose of 600 or 3750 IU/d. The homeostasis model assessment (HOMA) of IR index at 1 y was the primary outcome. We also assessed the McAuley index.

resultsIn total, 222 subjects (55% women) with a mean ± SD age and body mass index (BMI; in kg/m(2)) of 71 ± 4 y and 30 ± 4, respectively, completed the study. Subjects' baseline characteristics, including IR indexes, were similar across groups: 69% had prediabetes, 54% had hypertension (47% were taking antihypertensive medications), and 60% had hyperlipidemia, nearly half of whom were receiving lipid-lowering drugs. At 1 y, mean ± SD serum 25(OH)D increased from 20 ± 7 to 26 ± 7 ng/mL in the low-dose arm (P < 0.0001) and from 21 ± 8 to 36 ± 10 ng/mL in the high-dose arm (P < 0.001). Median HOMA-IR indexes did not change compared with baseline concentrations and were similar in the high- [2.2 (IQR: 1.5, 2.9)] and low-dose [2.3 (IQR: 1.6, 3.3] treatment groups. Adjusted analyses showed that HOMA-IR was predicted by the baseline HOMA index and BMI but not by vitamin D dose, baseline serum 25(OH)D, or change in 25(OH)D.

conclusionVitamin 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.

Indexed as

Dietary SupplementsInsulin ResistanceObesityVitaminsAgedBody Mass IndexCholecalciferolComorbidityDouble-Blind MethodFemaleHumansMaleOverweightVitamin DVitamin D Deficiency25-hydroxyvitamin DCholecalciferolVitamin DVitaminshigh-dose vitamin DHOMAinsulin resistanceIOM RDAprediabetes

Identifiers

PMID27413130
PMCPMC4962162
OpenAlexW2466613455

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.