NCT01344161

Brief Summary

The investigators investigated the effect of vitamin D3 supplementation on metabolic profile (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in overweight or obese women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

October 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 3, 2012

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

April 18, 2011

Results QC Date

July 25, 2011

Last Update Submit

October 9, 2012

Conditions

OverweightObesity

Keywords

Vitamin DMetabolic profileOverweightObesity

Outcome Measures

Primary Outcomes (4)

  • Change in Body Fat Mass

    Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.

    3 months minus baseline

  • Change in Glucose Concentrations

    3 months minus baseline

  • Change in Post Load Glucose Concentrations

    It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).

    3 months minus baseline

  • Change in Insulin Concentrations

    3 months minus baseline

Study Arms (2)

Lactose

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Vitamin D

EXPERIMENTAL
Dietary Supplement: vitamin D

Interventions

PlaceboDIETARY_SUPPLEMENT

dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks

Also known as: Lactose
Lactose
vitamin DDIETARY_SUPPLEMENT

dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks

Also known as: Cholecalciferol
Vitamin D

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • years old
  • Premenopause
  • BMI ≥25

You may not qualify if:

  • Cardiovascular disease
  • Liver disease
  • Gastrointestinal disease
  • Kidney disease
  • Diabetes mellitus
  • Osteoporosis
  • Pregnancy
  • Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, 1416783913, Iran

Location

Related Publications (2)

  • Salehpour A, Shidfar F, Hosseinpanah F, Vafa M, Razaghi M, Amiri F. Does vitamin D3 supplementation improve glucose homeostasis in overweight or obese women? A double-blind, randomized, placebo-controlled clinical trial. Diabet Med. 2013 Dec;30(12):1477-81. doi: 10.1111/dme.12273. Epub 2013 Jul 27.

    PMID: 23822797DERIVED

  • Salehpour A, Hosseinpanah F, Shidfar F, Vafa M, Razaghi M, Dehghani S, Hoshiarrad A, Gohari M. A 12-week double-blind randomized clinical trial of vitamin D(3) supplementation on body fat mass in healthy overweight and obese women. Nutr J. 2012 Sep 22;11:78. doi: 10.1186/1475-2891-11-78.

    PMID: 22998754DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

LactoseVitamin DCholecalciferol

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Results Point of Contact

Title
Dr.Farzad Shidfar
Organization
Tehran University of Medical Sciences
f-shidfar@tums.ac.ir
09123082922

Study Officials

  • Farzad Shidfar, PhD

    Tehran University of Medical Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 28, 2011

Study Start

October 1, 2009

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

October 11, 2012

Results First Posted

July 3, 2012

Record last verified: 2012-10

Locations

IR(1)