Can Correction of Low Vitamin D Status in Infancy Program for a Leaner Body Composition?

NCT02563015 | Terminated

• 1 other identifier: HW-15-01
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

One in four infants are born with low amounts of vitamin D stored in their body. This study is designed to test whether improving vitamin D status quickly after birth helps infants to build muscle and to normalize growth. This is important since the investigators have noticed in previous work that infants with low vitamin D have higher body weight relative to body length later on and that those who develop very good stores quickly have a leaner body type. Therefore, in this study infants with low stores early after birth will be given either the regular amount of supplementation or a higher amount to more rapidly build up the vitamin stores in the body. Infants in both groups will be measured for muscle and fat mass at standardized ages during the first year of life and into the toddler years. The information will inform health care professionals and parents of the importance of establishing good vitamin D stores early in life. Vitamin D supplementation is a modifiable factor that is already recommended for all term born infants. Knowing how much is needed in infants born with low stores has not been tested in a controlled manner in Canada.

Conditions

Healthy; Vitamin D Deficiency; Gestational Diabetes

Keywords

Infant; Vitamin D; Deficiency; Lean Mass

Outcome Measures

Primary Outcomes (1)

• Lean mass

  Whole body lean mass

  Trial phase is 1-12 months with primary end-point of 12 months. The follow-on study is up to 3 years.

Secondary Outcomes (1)

• 25(OH)D, body composition (lean, fat, bone), bone density, biomarkers of vitamin D status, growth and bone.

  Trial phase 1-12 months; follow-on study up to 3 years

Study Arms (3)

Cholecalciferol 400

EXPERIMENTAL

400 IU orally per day

Dietary Supplement: cholecalciferol

Cholecalciferol 1000

EXPERIMENTAL

1000 IU orally per day

Dietary Supplement: cholecalciferol

Reference 400

ACTIVE COMPARATOR

400 IU orally per day

Dietary Supplement: Reference 400

Interventions

cholecalciferol DIETARY_SUPPLEMENT

liquid drops

Also known as: vitamin D3

Cholecalciferol 1000; Cholecalciferol 400

Reference 400 DIETARY_SUPPLEMENT

liquid drops

Also known as: vitaminD3

Reference 400

Eligibility Criteria

• Age: Up to 1 Week
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Term;
• Healthy;
• Appropriate weight for gestational age;
• Infants born to mothers with otherwise healthy pregnancy and free of medications that impact vitamin D metabolism (except vitamin/mineral supplements) or fetal growth and intent to breastfeed to at least 3 months;
• Infants born to mothers with gestational diabetes (screened for vitamin D status at birth and randomized to 400 or 1000 IU/d vitamin D under an ancillary arm of this study following the same protocol).

You may not qualify if:

• Preterm;
• Small for gestational age;
• Maternal smoking in pregnancy, diabetes (types 1 or 2), preeclampsia, celiac disease, inflammatory bowel disease and medications that impact vitamin D/mineral metabolism.

Sponsors & Collaborators

• McGill University: lead
• Health Canada: collaborator

Study Sites (1)

Mary Emily Clinical Nutrition Research Unit

Sainte-Anne-de-Bellevue, Quebec, H9X 2E3, Canada

Location

Related Publications (5)

• Razaghi M, Gharibeh N, Vanstone CA, Wei SQ, McNally D, Rauch F, Jones G, Heinonen K, Weiler HA. Can correction of low vitamin D status in infancy program for a leaner body composition? A posttrial follow-up study of whole body lean mass in early childhood. Am J Clin Nutr. 2025 Nov;122(5):1338-1350. doi: 10.1016/j.ajcnut.2025.09.002. Epub 2025 Sep 9.

  PMID: 40935152 DERIVED

• Gharibeh N, Razaghi M, Vanstone CA, Sotunde OF, Glenn L, Mullahoo K, Farahnak Z, Khamessan A, Wei SQ, McNally D, Rauch F, Jones G, Kaufmann M, Weiler HA. Effect of Vitamin D Supplementation on Bone Mass in Infants With 25-Hydroxyvitamin D Concentrations Less Than 50 nmol/L: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2023 Apr 1;177(4):353-362. doi: 10.1001/jamapediatrics.2022.5837.

  PMID: 36780180 DERIVED

• Weiler HA, Attar A, Farahnak Z, Sotunde OF, Razaghi M, Gharibeh N, Khamessan A, Vanstone CA. Vitamin D Status of Infants of Mothers with Gestational Diabetes: Status at Birth and a Randomized Controlled Trial of Vitamin D Supplementation across Infancy. J Nutr. 2022 Nov;152(11):2441-2450. doi: 10.1093/jn/nxac194. Epub 2022 Sep 23.

  PMID: 36774110 DERIVED

• Razaghi M, Gharibeh N, Vanstone CA, Sotunde OF, Khamessan A, Wei SQ, McNally D, Rauch F, Jones G, Kimmins S, Weiler HA. Correction of neonatal vitamin D status using 1000 IU vitamin D/d increased lean body mass by 12 months of age compared with 400 IU/d: a randomized controlled trial. Am J Clin Nutr. 2022 Jun 7;115(6):1612-1625. doi: 10.1093/ajcn/nqab431.

  PMID: 35441210 DERIVED

• Weiler HA, Vanstone CA, Razaghi M, Gharibeh N, Patel S, Wei SQ, McNally D. Disparities in Vitamin D Status of Newborn Infants from a Diverse Sociodemographic Population in Montreal, Canada. J Nutr. 2022 Jan 11;152(1):255-268. doi: 10.1093/jn/nxab344.

  PMID: 34612495 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Diabetes, Gestational

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Hope Weiler, PhD.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor at time of the study launch.

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 29, 2015
• Study Start: March 7, 2016
• Primary Completion: September 20, 2020
• Study Completion: September 20, 2020
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)