Clinical trial NCT01631292: Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
Official title: A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 81
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bone mineral density (BMD)
timeFrame: 1 year
measure: Bone quality
timeFrame: 1 year
Secondary outcomes:
measure: Bone turnover markers
timeFrame: Baseline, 6 months, 12 months
measure: Glycemic indices
timeFrame: Baseline, 6 months and 12 months
measure: Cognition and biochemical markers
timeFrame: One year
measure: cholesterol absorption
timeFrame: baseline and one year
measure: serum vitamin D
timeFrame: Baseline, 6 months and 12 months
measure: Bone regulating hormones
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University- Thompson Hall
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Sue Shapses, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11.