Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)

Osteoporosis Clinical Trial

Official title:

A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631292
• Other study ID #: BBGP201095157
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese women, and hypothesize that it will not affect areal BMD, but will alter bone compartments (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum 25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes include the influence of vitamin D and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 30, 2019
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 72 Years

Eligibility

Inclusion Criteria:

• Body mass index of 25-40 kg/m2

• Postmenopausal

• Age 50-72 years

Exclusion Criteria:

• Women who are taking any medication known to influence Calcium or bone metabolism,

• Evidence of diseases known to influence Calcium metabolism (i.e. metabolic bone disease)

• hyperparathyroidism

• untreated thyroid disease

• significant immune disease

• hepatic disease

• renal disease or a kidney stone in the last 5 years

• significant cardiac disease

• active malignancy or cancer therapy within the past year

Related Conditions & MeSH terms

• Osteoporosis
• Weight Loss

Intervention

Dietary Supplement:
• 600 IU Vitamin D3
Once daily
• 2000 IU Vitamin D3
Once daily
• 4000 IU Vitamin D3
Once daily

Locations

Country	Name	City	State
United States	Rutgers University- Thompson Hall	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Castle M, Fiedler N, Pop LC, Schneider SJ, Schlussel Y, Sukumar D, Hao L, Shapses SA. Three Doses of Vitamin D and Cognitive Outcomes in Older Women: A Double-Blind Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):835-842. doi: 10.1093/gerona/glz041. — View Citation

Pop LC, Sukumar D, Schneider SH, Schlussel Y, Stahl T, Gordon C, Wang X, Papathomas TV, Shapses SA. Three doses of vitamin D, bone mineral density, and geometry in older women during modest weight control in a 1-year randomized controlled trial. Osteoporos Int. 2017 Jan;28(1):377-388. doi: 10.1007/s00198-016-3735-z. Epub 2016 Aug 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density (BMD)	BMD	1 year
Primary	Bone quality	thickness (mm)	1 year
Secondary	Bone turnover markers	osteocalcin (others include PINP and CTX)	Baseline, 6 months, 12 months
Secondary	Glycemic indices	glucose and insulin	Baseline, 6 months and 12 months
Secondary	Cognition and biochemical markers	Cognitive measures and serum biochemical markers	One year
Secondary	cholesterol absorption	Serum levels	baseline and one year
Secondary	serum vitamin D	25(OH)D	Baseline, 6 months and 12 months
Secondary	Bone regulating hormones	PTH	Baseline, 6 months and 12 months