Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

NCT03310307 | Completed Phase 2

• 1 other identifier: Hcy-VitD-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine concentrations were measured before intervention (basal), on 30 days (one month) and on 60 days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo and vitamin D group over time showed significant difference on 30 and 60 days of intervention. Mean comparisons of homocysteine concentrations and standard error of the means before and after intervention showed statistical significant decrease in homocysteine concentrations among vitamin D group.

Conditions

Homocystinaemia; Vitamin D Deficiency

Keywords

Homocysteine; Overweight; vitamin D3; Reproductive women; RCT

Outcome Measures

Primary Outcomes (1)

• 25(OH)D3

  vitamin D in serum

  2 months

Secondary Outcomes (1)

• Homocysteine

  2 months

Study Arms (2)

vitamin D3

ACTIVE COMPARATOR

50,000 IU

Drug: Vit D

Placebo

PLACEBO COMPARATOR

Similar in size, shape and color to vitamin D3

Other: Placebo

Interventions

Vit D DRUG

50,000 IU

Also known as: Biodal

vitamin D3

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Attending obstetric and gynecology clinics at King Abdullah University Hospital
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight (BMI between 25-29.99 kg/m2)
• Had 25(OH)D \< 20 ng/mL
• Had normal vitamin B-12 and folic acid levels
• Not diagnosed with any chronic diseases
• Agreed to participat in the study

You may not qualify if:

• age \< 18 or \> 49 years
• BMI \> 30 kg/m2 or \< 25 kg/m2
• (OH)D level \> 20 ng/ml
• tHcy levels greater than 100 µmol/L
• Abnormal vitamin B-12 or folic acid levels
• Chronic diseases
• Pregnant or lactating

Sponsors & Collaborators

• Al-Balqa Applied University: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

King Abdullah University Hospital

Irbid, Jordan

Location

Related Publications (1)

• Al-Bayyari N, Al-Zeidaneen S, Hailat R, Hamadneh J. Vitamin D3 prevents cardiovascular diseases by lowering serum total homocysteine concentrations in overweight reproductive women: A randomized, placebo-controlled clinical trial. Nutr Res. 2018 Nov;59:65-71. doi: 10.1016/j.nutres.2018.07.012. Epub 2018 Jul 29.

  PMID: 30442234 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Overweight

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jehan M Hamadneh, FRCOG

  JUST

  PRINCIPAL INVESTIGATOR

• Nahla S Al-Bayyari, PhD

  BAU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 16, 2017
• Study Start: April 1, 2016
• Primary Completion: August 30, 2016
• Study Completion: October 30, 2016
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

JO (1)