NCT00949832

Brief Summary

The purpose of this study is:

  1. 1.To compare the response of rickets to calcium with and without vitamin D.
  2. 2.To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.
  3. 3.To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2
  4. 4.To identify mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh.
  5. 5.To assess the functional status of the 25-hydroxylase enzyme in families possessing a 25-hydroxylase mutation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

July 29, 2009

Last Update Submit

July 3, 2012

Conditions

Nutritional Rickets

Keywords

ricketscalciumvitamin Dnutritionchild

Outcome Measures

Primary Outcomes (1)

  • XR healing of rickets

    6 months

Secondary Outcomes (5)

  • Alkaline phosphatase

    6 months

  • Serum calcium

    6 months

  • 25-hydroxyvitamin D

    6 months

  • 1,25-dihydroxyvitamin D

    2 weeks

  • Calcium absorption

    1 week

Study Arms (4)

Vitamin D + Calcium

ACTIVE COMPARATOR

Vitamin D and calcium supplementation

Dietary Supplement: Vitamin D + Calcium

Calcium

PLACEBO COMPARATOR

Calcium supplementation

Dietary Supplement: Calcium

Vitamin D2

ACTIVE COMPARATOR

Vitamin D2 response

Dietary Supplement: Vitamin D2

Vitamin D3

ACTIVE COMPARATOR

Vitamin D3 response

Dietary Supplement: Vitamin D3

Interventions

Vitamin D + CalciumDIETARY_SUPPLEMENT

Vitamin D 50,000 IU orally once monthly for 6 months; Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months

Also known as: ergocalciferol
Vitamin D + Calcium
CalciumDIETARY_SUPPLEMENT

Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months; Vitamin B complex (used as placebo) 1 tablet monthly for 6 months

Also known as: limestone
Calcium
Vitamin D2DIETARY_SUPPLEMENT

50,000 IU given orally once

Also known as: ergocalciferol
Vitamin D2
Vitamin D3DIETARY_SUPPLEMENT

Vitamin D3 50,000 IU given orally once

Also known as: cholecalciferol
Vitamin D3

Eligibility Criteria

Age6 Months - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Clinical features of rickets
  • Active rickets on X-ray

You may not qualify if:

  • Treatment with calcium or vitamin D in preceding 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jos University Teaching Hospital

Jos, Plateau State, 930001, Nigeria

Location

Related Publications (6)

  • Thacher TD, Fischer PR, Pettifor JM, Lawson JO, Isichei CO, Reading JC, Chan GM. A comparison of calcium, vitamin D, or both for nutritional rickets in Nigerian children. N Engl J Med. 1999 Aug 19;341(8):563-8. doi: 10.1056/NEJM199908193410803.

    PMID: 10451461BACKGROUND

  • Graff M, Thacher TD, Fischer PR, Stadler D, Pam SD, Pettifor JM, Isichei CO, Abrams SA. Calcium absorption in Nigerian children with rickets. Am J Clin Nutr. 2004 Nov;80(5):1415-21. doi: 10.1093/ajcn/80.5.1415.

    PMID: 15531695BACKGROUND

  • Thacher TD, Fischer PR, Isichei CO, Pettifor JM. Early response to vitamin D2 in children with calcium deficiency rickets. J Pediatr. 2006 Dec;149(6):840-4. doi: 10.1016/j.jpeds.2006.08.070.

    PMID: 17137904BACKGROUND

  • Fischer PR, Thacher TD, Pettifor JM, Jorde LB, Eccleshall TR, Feldman D. Vitamin D receptor polymorphisms and nutritional rickets in Nigerian children. J Bone Miner Res. 2000 Nov;15(11):2206-10. doi: 10.1359/jbmr.2000.15.11.2206.

    PMID: 11092401BACKGROUND

  • Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

    PMID: 33305842DERIVED

  • Thacher TD, Fischer PR, Pettifor JM. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial. Arch Dis Child. 2014 Sep;99(9):807-11. doi: 10.1136/archdischild-2013-305275. Epub 2014 Apr 19.

    PMID: 24748637DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyRickets

Interventions

Vitamin DCalciumErgocalciferolsCalcium CarbonateCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesCalcium Metabolism Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsCholestenesCholestanesSterolsMembrane LipidsLipidsCalcium CompoundsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Thomas D Thacher, MD

    Mayo Clinic, Jos University Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

January 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

NG(1)