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Completed

NCT Number: NCT03735303

Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency

The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Science University

Amman, 11931, Jordan

About this study

Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)

This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • jordanian people aged 25-55
  • medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)

Exclusion criteria

  • Blood disorders including
  • thalassemia
  • sickle cell disease

Treatment and study plan

VD3 group

Dietary Supplement

VD3 50000 IU/ week for 8 weeks

omega 3 FA group

Dietary Supplement

omega 3 FA group 300 mg once daily for 8 weeks

VD3 and omega- 3FA group

Dietary Supplement

50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks

Control Group

Other

no intervention was given

Primary outcomes

  1. VD 3

    Time frame: 8 weeks

    Serum level of 25-hydroxyvitamin D

  2. leptin

    Time frame: 8 weeks

    serum level of leptin

  3. HbA1C

    Time frame: 8 weeks

    plasma concentration of HbA1C

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Official study title

The Combined Effect of Vitamin D3 and Omega-3 Supplements on Serum Leptin and Glycated Hemoglobin (Hb A1C) Levels in Jordanian People With Vitamin D Deficiency.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2018
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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