NCT02942732

Brief Summary

The investigators examined the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

October 16, 2016

Last Update Submit

October 21, 2016

Conditions

Insulin Resistance

Keywords

Vitamin DGlucoseHbA1CInsulin resistanceBlood lipids

Outcome Measures

Primary Outcomes (4)

  • Fasting blood glucose (mmol/l)

    Change in Fasting blood glucose in mmol/l

    Baseline and 6 months

  • HbA1C (%)

    Change in HbA1C (%)

    Baseline and 6 months

  • HOMA-IR

    Change in HOMA-IR

    Baseline and 6 months

  • Fasting Insulin (mIU/L)

    Change in Fasting Insulin (mIU/L)

    Baseline and 6 months

Study Arms (4)

normal-weight adult subjects

OTHER

normal-weight adult subjects (n=30, age ≤ 65 years and BMI ≤ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.

Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)

overweight adult subjects

OTHER

overweight adult subjects (n=30, age ≤ 65 years and BMI ≥ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.

Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)

normal-weight elderly

OTHER

normal-weight elderly (n=60, age ≥ 65 years and BMI ≤ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.

Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)

overweight elderly

OTHER

overweight elderly (n=60, age ≥ 65 years and BMI ≥ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.

Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)

Interventions

cholecalciferol (Euro-Pharm International, Canada)DIETARY_SUPPLEMENT

All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.

normal-weight adult subjectsnormal-weight elderlyoverweight adult subjectsoverweight elderly

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with no medical history of congestive heart failure, acute heart insufficiency and renal failure were included

You may not qualify if:

  • Participants with medical history of congestive heart failure, acute heart insufficiency and renal failure were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Nagpal J, Pande JN, Bhartia A. A double-blind, randomized, placebo-controlled trial of the short-term effect of vitamin D3 supplementation on insulin sensitivity in apparently healthy, middle-aged, centrally obese men. Diabet Med. 2009 Jan;26(1):19-27. doi: 10.1111/j.1464-5491.2008.02636.x.

    PMID: 19125756RESULT

  • Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.

    PMID: 17389701RESULT

MeSH Terms

Conditions

Insulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Stephane Walrand, PhD

    Auvergne Univeristy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2016

First Posted

October 24, 2016

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

October 24, 2016

Record last verified: 2016-10